Zweckbestimmung von Medizinprodukten richtig formulieren
•Als PPTX, PDF herunterladen•
0 gefällt mir•44,934 views
Eine korrekt formulierte Zweckbestimmung ist nicht nur für Mobile Medical Apps eine Voraussetzung, um zu entscheiden, ob das Produkt ein Medizinprodukt ist und unter die entsprechenden Richtlinien, Gesetze, Verordnungen und Regularien fällt. Die Zweckbestimmung ist auch die Basis für die Klassifizierung nach MDR, für das Risikomanagement (gemäß ISO 14971) und für die Sicherheitsklassifizierung nach IEC 62304. Vielen Medizinprodukte-Hersteller unterlaufen beim (impliziten) Formulierung der Zweckbestimmung Fehler, die zu fatalen rechtlichen Konsequenzen führen können. Diese kurze Präsentation verrät, wie Sie eine Zweckbestimmung (nicht nur) für Medizinprodukte korrekt formulieren.
Melden
Teilen
Melden
Teilen
Empfohlen
Clinical development of biopharmaceuticals in India
This document discusses the regulatory requirements for clinical development of biosimilars in India. It provides an overview of the applicable regulations, guidelines, and authorities overseeing clinical trials. The key principles for developing biosimilars are to demonstrate comparability to the reference biologic through a stepwise characterization and clinical development program involving pharmacokinetic, pharmacodynamic, and confirmatory safety and efficacy studies. Post-marketing requirements include pharmacovigilance plans and potential post-marketing studies to further evaluate safety and immunogenicity.
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...
The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims. Additional benefits may include your product being made safer for end-users. The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. If you manufacture or import a product which falls within the scope of one or more of the New Approach Directives and wish to place your product on the market in any of the member’s states of the European Economic Area (EEA), then you must apply CE marking to your product against the essential requirements of all these applicable directives.
Key Words: European Union, CE marking, New Approach Directives, EEA, Regulatory requirements.
NLP in Healthcare to Predict Adverse Events with Amazon SageMaker (AIM346) - ...
In healthcare, pharmacovigilance is key to improving patient outcomes. The prediction of adverse events will enable pharmaceutical companies and drug distributors in accurately meeting their pharmacovigilance requirements and scaling their operations. In this chalk talk, we discuss how Amazon SageMaker can be used to classify large-scale agent and reporter interaction summaries. We also discuss natural language processing (NLP) methods and results.
IEC 62304: SDLC Conformance and Management
This presentation was delivered as a webinar for FDAnews, delving into software, medical devices and managing risk with 21 CFR Part 11 and IEC 62304. It provides:
• A historical backdrop of IEC 62304
• An overview of IEC 62304
• Implementing IEC 62304
• Common pitfalls to avoid
Medical Devices Regulation (MDR) 2017/745 - Clinical investigations
Medical Devices Regulation (MDR) 2017/745 - Clinical investigations
See more https://www.aretezoe.com/medical-devices
China: Medical Device Regulations
This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
IEC 62304 Action List
IEC 62304 is an international standard that defines software development lifecycle requirements for medical device software. It requires that all aspects of the software development life cycle be scrutinized to ensure patient safety when software is involved. The standard establishes software safety classes A, B, and C based on the possible risk to health from software failures. It also outlines numerous requirements for each class, including developing plans, requirements, designs, testing procedures, problem resolution processes, and more. Upon completion, all documentation should be submitted to a test lab for review to obtain certification.
Adverse Event reporting in Medical Device Clinical Trials under the MDR
With the change from MDD to MDR Adverse Event (AE) reporting in Medical Device Clinical Trials is supposed to be more clear and uniform, but is it?
Conclusion is that at this moment it is not due to several reasons, the main ones being that the clinical module in EUDAMED is not ready yet leading to different reporting requirements for the different EU countries, and that the MDR focusses on reporting to the Competent Authorities and central or local Ethics Committees may have different reporting requirements.
So regardless MDR directions, it is key to check AE reporting needs with every regulatory body involved at the start of your Medical Device Clinical Trial to make sure you are compliant with the applicable requirements.
Empfohlen
Clinical development of biopharmaceuticals in India
This document discusses the regulatory requirements for clinical development of biosimilars in India. It provides an overview of the applicable regulations, guidelines, and authorities overseeing clinical trials. The key principles for developing biosimilars are to demonstrate comparability to the reference biologic through a stepwise characterization and clinical development program involving pharmacokinetic, pharmacodynamic, and confirmatory safety and efficacy studies. Post-marketing requirements include pharmacovigilance plans and potential post-marketing studies to further evaluate safety and immunogenicity.
Regulatory requirements for CE CERTIFICATION of Medical Devices in European U...
The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. In addition, it may be considered a benefit that by implementing the requirements, the product will be safer for the user and this may also reduce damage and liability claims. Additional benefits may include your product being made safer for end-users. The EU introduced the CE marking scheme to make trade easier and cheaper between EU countries. It means that a manufacturer claims that their product conforms to the minimum legal requirements for health and safety as laid down in EU directives. If you manufacture or import a product which falls within the scope of one or more of the New Approach Directives and wish to place your product on the market in any of the member’s states of the European Economic Area (EEA), then you must apply CE marking to your product against the essential requirements of all these applicable directives.
Key Words: European Union, CE marking, New Approach Directives, EEA, Regulatory requirements.
NLP in Healthcare to Predict Adverse Events with Amazon SageMaker (AIM346) - ...
In healthcare, pharmacovigilance is key to improving patient outcomes. The prediction of adverse events will enable pharmaceutical companies and drug distributors in accurately meeting their pharmacovigilance requirements and scaling their operations. In this chalk talk, we discuss how Amazon SageMaker can be used to classify large-scale agent and reporter interaction summaries. We also discuss natural language processing (NLP) methods and results.
IEC 62304: SDLC Conformance and Management
This presentation was delivered as a webinar for FDAnews, delving into software, medical devices and managing risk with 21 CFR Part 11 and IEC 62304. It provides:
• A historical backdrop of IEC 62304
• An overview of IEC 62304
• Implementing IEC 62304
• Common pitfalls to avoid
Medical Devices Regulation (MDR) 2017/745 - Clinical investigations
Medical Devices Regulation (MDR) 2017/745 - Clinical investigations
See more https://www.aretezoe.com/medical-devices
China: Medical Device Regulations
This whitepaper provides an overview of Chinese Medical Device Regulations. This includes an overview of the Chinese medical device market, medical device regulatory authorities, medical device registration procedure and medical device classification. It also provides information on regulations regarding product standard, type testing, and clinical trials. This paper is meant for anyone within the regulatory affairs industry who is looking to learn more about medical device regulations and product registration in China.
For more information, contact us for a free 15 minute consultation at http://www.pacificbridgemedical.com/contact-us/.
IEC 62304 Action List
IEC 62304 is an international standard that defines software development lifecycle requirements for medical device software. It requires that all aspects of the software development life cycle be scrutinized to ensure patient safety when software is involved. The standard establishes software safety classes A, B, and C based on the possible risk to health from software failures. It also outlines numerous requirements for each class, including developing plans, requirements, designs, testing procedures, problem resolution processes, and more. Upon completion, all documentation should be submitted to a test lab for review to obtain certification.
Adverse Event reporting in Medical Device Clinical Trials under the MDR
With the change from MDD to MDR Adverse Event (AE) reporting in Medical Device Clinical Trials is supposed to be more clear and uniform, but is it?
Conclusion is that at this moment it is not due to several reasons, the main ones being that the clinical module in EUDAMED is not ready yet leading to different reporting requirements for the different EU countries, and that the MDR focusses on reporting to the Competent Authorities and central or local Ethics Committees may have different reporting requirements.
So regardless MDR directions, it is key to check AE reporting needs with every regulatory body involved at the start of your Medical Device Clinical Trial to make sure you are compliant with the applicable requirements.
Handling of Out of Specification Results
This presentation gives an overview to handle Out of Specification Results based on US FDA guidance.
Content and format of dossier filling in india
This document provides an overview of the dossier submission process for drug approval. It discusses the Common Technical Document (CTD) format adopted by the Central Drugs Standard Control Organization of India based on International Conference on Harmonization guidelines. The CTD format organizes the dossier into five modules containing administrative information, quality data, nonclinical studies, clinical studies and references. Compliance with the CTD format and inclusion of all required information is necessary for regulatory approval of new drugs.
21 cfr part 11 compliance
21CFR regulations & its applicability in the industry and FDA perspective on the same and FDA check points on 21CFR regulations during their inspection.
Clinical Evaluation Report for Medical Devices
As per MEDDEV 2.7/1 Rev.4, Clinical Evaluation is a specialized robust method to collect, appraise and analyze clinical data related to a medical device and to interpret if there is satisfactory clinical information (evidence) to establish conformity with pertinent essential requirements for safety and performance when employing the medical device as per the manufacturer's instructions for use.
QMS for Medical Devices.pptx
This document provides an overview of quality management systems for medical devices. It discusses ISO 13485, the international quality standard for medical device quality management systems. It outlines the pathway for setting up a quality management system that is compliant with ISO 13485 and applicable regulations. This includes planning the system, documenting policies and procedures, management reviews, and third party audits. The document also discusses standards and regulations from organizations like the FDA, EU, and Health Canada. It covers the certification process for quality management systems and medical devices. Finally, it discusses how technology can be leveraged to support quality management systems.
regulatory aspects of medical devices in USA
introduction, classification, regulatory approval process for medical devices (510k) premarket notification, pre market approval (PMA), investigational device exemption (IDE) and invitro diagnostics, quality system requirements 21 CFR PART 820, labeling requirements 21 CFR part 801, UDI
Regulation of software as medical devices
Software can be regulated as a medical device if it meets the definition under Australian law. The intended purpose of the software must be for diagnosis, prevention, monitoring, treatment or alleviation of disease or injury. Regulators are working to clarify how quality management system principles apply to software. Post-market, issues can include software crossing regulatory lines over multiple upgrades and not properly reporting safety incidents.
Medical Device Regulations - 510(k) Process
This document provides an overview of the 510(k) premarket notification process required by the FDA for medical devices. It explains that the 510(k) process requires manufacturers to demonstrate that new devices are substantially equivalent to existing legally marketed predicate devices. The document outlines the key requirements for submitting a 510(k), including when one is necessary, who must submit one, what information must be included, and scenarios where a 510(k) is not required. It also provides details on the review process and requirements for devices that are cleared through the 510(k) pathway.
Drug approval process in japan
1. The PMDA (Pharmaceuticals and Medical Devices Agency) is the Japanese regulatory agency that reviews submissions for drug and medical device approval to ensure safety, efficacy, and quality. It was established in 2004.
2. To market a drug in Japan, approval must be obtained for each product by demonstrating efficacy and safety through examinations. Foreign manufacturers must be accredited through the FMA process. Medical devices are classified and require pre-market notification, certification, or approval depending on the risk class.
3. Registering products in Japan requires navigating a complex process that can involve clinical trials and high fees. Pursuing product registration requires carefully considering the market demand to determine if pursuing approval is worthwhile.
New European Medical Device Regulations: Keeping Your Orthopaedic and Spine ...
For years, notified bodies and industry experts have warned orthopaedic device companies to prepare for the forthcoming EU Medical Device Regulation (MDR). Though the regulation is expected to be officially published in the first half of 2017, a recent study shows that not only are companies not prepared, but regulatory and quality affairs professionals say that they have not studied the regulation closely.
The regulation includes new requirements for orthopaedic (and especially spine) companies that must be met in a timely manner to keep products on the market. Among the MDR changes are more stringent clinical evidence, identification of a “qualified person,” implementation of UDI and rigorous postmarket oversight.
Dr. Li covers highlights of the regulation and the provided transition period toward fulfillment of the new expectations. He explains the impact of device up-classification and the need for additional clinical data toward passing this new regulation successfully and toward fulfilling the postmarket reporting requirements accordingly.
ADaM
This document provides an overview of ADaM (Analysis Data Model) and recommendations for getting started with ADaM specification development, programming, and quality control (QC). It discusses:
1) Starting ADaM specification development by identifying analysis datasets needed based on the SAP and using a clear template to define required variables and attributes.
2) Beginning ADaM programming by understanding the source SDTM datasets and ADaM specifications, including how complex algorithms and derivations are defined.
3) Initiating ADaM QC by checking that analysis variables can be traced back to SDTM, comply with the ADaM IG, and support required analysis results. Simple programming and use of
TGA presentation: Data Integrity - an international regulatory perspective
This document discusses data integrity from an international regulatory perspective. It provides an overview of guidance documents from various regulatory agencies on data integrity expectations. Key points covered include that data integrity is not a new requirement, but rather has always been expected under good manufacturing practices. Regulators are increasing their focus and collaboration around data integrity inspections. The document also addresses common misconceptions, such as thinking data integrity only applies to fraudulent data or is difficult to comply with. Effective strategies for ensuring data integrity involve a lifecycle approach considering culture, governance, procedures, systems, and behavior.
Medical Devices Regulation (MDR) 2017/745 - Part I Purpose, Scope, Definitions
This document provides an overview and summary of key changes and requirements in the new Medical Device Regulation (EU) 2017/745, which replaces previous directives. Some of the main changes include expanding the scope of regulated devices, implementing a Unique Device Identifier system for traceability, increasing requirements for clinical evidence and post-market surveillance, and removing grandfathering provisions. The purpose, scope, definitions and objectives are outlined to define the rules for placing medical devices on the EU market while ensuring a high level of safety and performance.
Waters: Reviewing Audit Trail Information in Empower Chromatography Data Soft...
This presentation provides an overview of how to review audit trail information within Waters Empower Chromatography Data Software. (From Inform 2016, our annual software users meeting)
MDR and class I medical devices presentation
The document summarizes key points about the transition from the Medical Device Directive (MDD) Class I to the new Medical Device Regulation (MDR) Class I, which takes effect on May 26, 2020. It notes that some MDD Class I devices will be upclassified under the MDR. These devices have until May 26, 2024 to obtain an MDR certificate through a two-step soft transition process. There are also significant gaps between the MDD and MDR requirements regarding technical documentation, quality management systems, clinical evidence requirements, and other areas that will take time for manufacturers to address.
Compliance with medical standards iec 62304, iso 14971, iec 60601, fda title ...
Compliance with medical standards iec 62304, iso 14971, iec 60601, fda title ...Intland Software GmbH
Check out our latest webinar to learn more about complying with IEC 62304, ISO 14971, IEC 60601, and relevant FDA regulations (for instance, Title 21 CFR Part 11 about electronic signatures). In this webinar, we discussed the requirements set forth by these standards. We also showed our Intland's Medical IEC 62304 Template to leverage codeBeamer ALM's advanced capabilities and to facilitate compliance with these regulations.Overview of FDA Regulation of Medical Devices
The document is a slide presentation by Michael A. Swit, Esq. on an overview of FDA regulation, with an emphasis on medical devices. It begins with definitions of key terms under FDA regulation such as drugs, biologics, devices, foods, dietary supplements, and cosmetics. It then discusses the mission and structure of the FDA, including the different centers that regulate specific product areas. The presentation provides an overview of the classification system for medical devices and regulatory pathways for devices, including 510(k) clearance and premarket approval.
GHTF Group 1
GHTF group 1 is about pre market evaluation .This ppt includes brief about the group 1 , about ghtf , what it includes , study groups , definitions , classification and its rules
ICH- Q3 Impurity
This document discusses ICH guidelines related to impurities in new drug substances and products. It defines key terms like impurity, identified impurity, and potential impurity. It categorizes impurities as organic, inorganic, or residual solvents. The guidelines provide thresholds for identification, qualification, and reporting of impurities. They also classify residual solvents and elemental impurities based on their toxicity, providing permissible daily exposure limits. The guidelines aim to establish qualification of impurities at levels present in early clinical trials and provide a risk-based approach to control impurities.
Quality, Safety and Legislation of Herbal Products in India
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
Medical devices: 7 steps to CE-mark, and post-market surveillance
The 7 steps medical device manufacturers have to take to fulfill the requirements of EU-MDR (medical medical device regulation) and to obtain the CE mark. The quick start guide.
Konformitätsbewertung: In 7 Schritten zum CE-Zeichen für Ihr Medizinprodukt
Medizinprodukte müssen ein CE-Zeichen tragen. Die Hersteller müssen dazu ein Konformitätsbewertungsverfahren durchlaufen. Diese Präsentation verrät Ihnen, wie Sie in 7 Schritten zum CE-Zeichen für Ihr Medizinprodukt kommen.
Weitere ähnliche Inhalte
Was ist angesagt?
Handling of Out of Specification Results
This presentation gives an overview to handle Out of Specification Results based on US FDA guidance.
Content and format of dossier filling in india
This document provides an overview of the dossier submission process for drug approval. It discusses the Common Technical Document (CTD) format adopted by the Central Drugs Standard Control Organization of India based on International Conference on Harmonization guidelines. The CTD format organizes the dossier into five modules containing administrative information, quality data, nonclinical studies, clinical studies and references. Compliance with the CTD format and inclusion of all required information is necessary for regulatory approval of new drugs.
21 cfr part 11 compliance
21CFR regulations & its applicability in the industry and FDA perspective on the same and FDA check points on 21CFR regulations during their inspection.
Clinical Evaluation Report for Medical Devices
As per MEDDEV 2.7/1 Rev.4, Clinical Evaluation is a specialized robust method to collect, appraise and analyze clinical data related to a medical device and to interpret if there is satisfactory clinical information (evidence) to establish conformity with pertinent essential requirements for safety and performance when employing the medical device as per the manufacturer's instructions for use.
QMS for Medical Devices.pptx
This document provides an overview of quality management systems for medical devices. It discusses ISO 13485, the international quality standard for medical device quality management systems. It outlines the pathway for setting up a quality management system that is compliant with ISO 13485 and applicable regulations. This includes planning the system, documenting policies and procedures, management reviews, and third party audits. The document also discusses standards and regulations from organizations like the FDA, EU, and Health Canada. It covers the certification process for quality management systems and medical devices. Finally, it discusses how technology can be leveraged to support quality management systems.
regulatory aspects of medical devices in USA
introduction, classification, regulatory approval process for medical devices (510k) premarket notification, pre market approval (PMA), investigational device exemption (IDE) and invitro diagnostics, quality system requirements 21 CFR PART 820, labeling requirements 21 CFR part 801, UDI
Regulation of software as medical devices
Software can be regulated as a medical device if it meets the definition under Australian law. The intended purpose of the software must be for diagnosis, prevention, monitoring, treatment or alleviation of disease or injury. Regulators are working to clarify how quality management system principles apply to software. Post-market, issues can include software crossing regulatory lines over multiple upgrades and not properly reporting safety incidents.
Medical Device Regulations - 510(k) Process
This document provides an overview of the 510(k) premarket notification process required by the FDA for medical devices. It explains that the 510(k) process requires manufacturers to demonstrate that new devices are substantially equivalent to existing legally marketed predicate devices. The document outlines the key requirements for submitting a 510(k), including when one is necessary, who must submit one, what information must be included, and scenarios where a 510(k) is not required. It also provides details on the review process and requirements for devices that are cleared through the 510(k) pathway.
Drug approval process in japan
1. The PMDA (Pharmaceuticals and Medical Devices Agency) is the Japanese regulatory agency that reviews submissions for drug and medical device approval to ensure safety, efficacy, and quality. It was established in 2004.
2. To market a drug in Japan, approval must be obtained for each product by demonstrating efficacy and safety through examinations. Foreign manufacturers must be accredited through the FMA process. Medical devices are classified and require pre-market notification, certification, or approval depending on the risk class.
3. Registering products in Japan requires navigating a complex process that can involve clinical trials and high fees. Pursuing product registration requires carefully considering the market demand to determine if pursuing approval is worthwhile.
New European Medical Device Regulations: Keeping Your Orthopaedic and Spine ...
For years, notified bodies and industry experts have warned orthopaedic device companies to prepare for the forthcoming EU Medical Device Regulation (MDR). Though the regulation is expected to be officially published in the first half of 2017, a recent study shows that not only are companies not prepared, but regulatory and quality affairs professionals say that they have not studied the regulation closely.
The regulation includes new requirements for orthopaedic (and especially spine) companies that must be met in a timely manner to keep products on the market. Among the MDR changes are more stringent clinical evidence, identification of a “qualified person,” implementation of UDI and rigorous postmarket oversight.
Dr. Li covers highlights of the regulation and the provided transition period toward fulfillment of the new expectations. He explains the impact of device up-classification and the need for additional clinical data toward passing this new regulation successfully and toward fulfilling the postmarket reporting requirements accordingly.
ADaM
This document provides an overview of ADaM (Analysis Data Model) and recommendations for getting started with ADaM specification development, programming, and quality control (QC). It discusses:
1) Starting ADaM specification development by identifying analysis datasets needed based on the SAP and using a clear template to define required variables and attributes.
2) Beginning ADaM programming by understanding the source SDTM datasets and ADaM specifications, including how complex algorithms and derivations are defined.
3) Initiating ADaM QC by checking that analysis variables can be traced back to SDTM, comply with the ADaM IG, and support required analysis results. Simple programming and use of
TGA presentation: Data Integrity - an international regulatory perspective
This document discusses data integrity from an international regulatory perspective. It provides an overview of guidance documents from various regulatory agencies on data integrity expectations. Key points covered include that data integrity is not a new requirement, but rather has always been expected under good manufacturing practices. Regulators are increasing their focus and collaboration around data integrity inspections. The document also addresses common misconceptions, such as thinking data integrity only applies to fraudulent data or is difficult to comply with. Effective strategies for ensuring data integrity involve a lifecycle approach considering culture, governance, procedures, systems, and behavior.
Medical Devices Regulation (MDR) 2017/745 - Part I Purpose, Scope, Definitions
This document provides an overview and summary of key changes and requirements in the new Medical Device Regulation (EU) 2017/745, which replaces previous directives. Some of the main changes include expanding the scope of regulated devices, implementing a Unique Device Identifier system for traceability, increasing requirements for clinical evidence and post-market surveillance, and removing grandfathering provisions. The purpose, scope, definitions and objectives are outlined to define the rules for placing medical devices on the EU market while ensuring a high level of safety and performance.
Waters: Reviewing Audit Trail Information in Empower Chromatography Data Soft...
This presentation provides an overview of how to review audit trail information within Waters Empower Chromatography Data Software. (From Inform 2016, our annual software users meeting)
MDR and class I medical devices presentation
The document summarizes key points about the transition from the Medical Device Directive (MDD) Class I to the new Medical Device Regulation (MDR) Class I, which takes effect on May 26, 2020. It notes that some MDD Class I devices will be upclassified under the MDR. These devices have until May 26, 2024 to obtain an MDR certificate through a two-step soft transition process. There are also significant gaps between the MDD and MDR requirements regarding technical documentation, quality management systems, clinical evidence requirements, and other areas that will take time for manufacturers to address.
Compliance with medical standards iec 62304, iso 14971, iec 60601, fda title ...
Compliance with medical standards iec 62304, iso 14971, iec 60601, fda title ...Intland Software GmbH
Check out our latest webinar to learn more about complying with IEC 62304, ISO 14971, IEC 60601, and relevant FDA regulations (for instance, Title 21 CFR Part 11 about electronic signatures). In this webinar, we discussed the requirements set forth by these standards. We also showed our Intland's Medical IEC 62304 Template to leverage codeBeamer ALM's advanced capabilities and to facilitate compliance with these regulations.Overview of FDA Regulation of Medical Devices
The document is a slide presentation by Michael A. Swit, Esq. on an overview of FDA regulation, with an emphasis on medical devices. It begins with definitions of key terms under FDA regulation such as drugs, biologics, devices, foods, dietary supplements, and cosmetics. It then discusses the mission and structure of the FDA, including the different centers that regulate specific product areas. The presentation provides an overview of the classification system for medical devices and regulatory pathways for devices, including 510(k) clearance and premarket approval.
GHTF Group 1
GHTF group 1 is about pre market evaluation .This ppt includes brief about the group 1 , about ghtf , what it includes , study groups , definitions , classification and its rules
ICH- Q3 Impurity
This document discusses ICH guidelines related to impurities in new drug substances and products. It defines key terms like impurity, identified impurity, and potential impurity. It categorizes impurities as organic, inorganic, or residual solvents. The guidelines provide thresholds for identification, qualification, and reporting of impurities. They also classify residual solvents and elemental impurities based on their toxicity, providing permissible daily exposure limits. The guidelines aim to establish qualification of impurities at levels present in early clinical trials and provide a risk-based approach to control impurities.
Quality, Safety and Legislation of Herbal Products in India
Herbal medicines are popular because of experience and the abundant
availability of plants in India due to its varied climatic zones. India has
around 45,000 species of plants, out of which 15,000–20,000 plants have
proven medicinal value.
Was ist angesagt? (20)
New European Medical Device Regulations: Keeping Your Orthopaedic and Spine ...
New European Medical Device Regulations: Keeping Your Orthopaedic and Spine ...
TGA presentation: Data Integrity - an international regulatory perspective
TGA presentation: Data Integrity - an international regulatory perspective
Medical Devices Regulation (MDR) 2017/745 - Part I Purpose, Scope, Definitions
Medical Devices Regulation (MDR) 2017/745 - Part I Purpose, Scope, Definitions
Waters: Reviewing Audit Trail Information in Empower Chromatography Data Soft...
Waters: Reviewing Audit Trail Information in Empower Chromatography Data Soft...
Compliance with medical standards iec 62304, iso 14971, iec 60601, fda title ...
Compliance with medical standards iec 62304, iso 14971, iec 60601, fda title ...
Quality, Safety and Legislation of Herbal Products in India
Quality, Safety and Legislation of Herbal Products in India
Mehr von Christian Johner
Medical devices: 7 steps to CE-mark, and post-market surveillance
The 7 steps medical device manufacturers have to take to fulfill the requirements of EU-MDR (medical medical device regulation) and to obtain the CE mark. The quick start guide.
Konformitätsbewertung: In 7 Schritten zum CE-Zeichen für Ihr Medizinprodukt
Medizinprodukte müssen ein CE-Zeichen tragen. Die Hersteller müssen dazu ein Konformitätsbewertungsverfahren durchlaufen. Diese Präsentation verrät Ihnen, wie Sie in 7 Schritten zum CE-Zeichen für Ihr Medizinprodukt kommen.
Konformitätsbewertung: In 7 Schritten zum CE-Zeichen für Ihr Medizinprodukt
Medizinprodukte müssen ein CE-Zeichen tragen. Die Hersteller müssen dazu ein Konformitätsbewertungsverfahren durchlaufen. Diese Präsentation verrät Ihnen, wie Sie in 7 Schritten zum CE-Zeichen für Ihr Medizinprodukt kommen.
CE-Zeichen für Medizinprodukte
In sieben Schritten zum CE-Zeichen für Ihr Medizinprodukt. Die Präsentation beschreibt den Weg von der Zweckbestimmung, über die Wahl des Konformitätsbewertungsverfahrens, die Klassifzierung, den Nachweis der grundlegenden Anforderungen mit harmonisierten Normen über die Konformitätserklärung und das Anbringen des CE-Zeichens bis zur Post-Market-Phase.
Weitere Unterstützung: www.johner-institut.de
Mobile Medical Apps - From Start to CE-Mark
The 5 steps to place your mobile medical app on the market including CE-mark. Learn to decide whether it is a medical device, learn to know the European regulations Medical Device Directive respectively Medical Device Regulation MDR and standards such as IEC 62304, ISO 14971 and IEC 62366.
Medical Apps: 5 Steps to CE-mark
http://www.johner-institut.de
The five to steps to develop and market your Medical App as a medical device compliant with European medical device regulations.
CE-Zeichen für Medizinprodukte
Lernen Sie, wie Sie Schritt für Schritt zum CE-Zeichen für Ihr Medizinprodukt kommen und dass es kein CE-Audit und keine Zulassung gibt.
Die Präsentation beschreibt den Weg von der Zweckbestimmung, über die Wahl des Konformitätsbewertungsverfahrens, die Klassifzierung, den Nachweis der grundlegenden Anforderungen mit harmonisierten Normen über die Konformitätserklärung und das Anbringen des CE-Zeichens bis zur Post-Market-Phase.
Medizinprodukte-Software: Ist QM-System notwendig?
Software kann Teil eines Medizinprodukts oder selbst ein Medizinprodukt sein (stand-alone Software). Viele Hersteller fragen sich, ob für die Entwicklung von "Medizinprodukte-Software" ein Qualitätsmanagementsystem (QM-System) notwendig ist. Diese kurze Präsentation gibt Antworten dazu.
Projektmanagement in der Medizintechnik
Ein Projektmanager in der Medizintechnik muss über spezifische Fähigkeiten und Kenntnisse verfügen. Beispielsweise muss er die einschlägigen Normen und Gesetze (z.B. IEC 62304, ISO 14971, ISO 13485) kennen, er muss wissen, über welche Kompetenzen die Entwickler verfügen müssen, und welche Prozessmodelle für Medizinprodukte erlaubt sind.
Mobile Medical Apps: In 5 Schritten zur "Medizinprodukte-Zertifizierung"
Mobile Medical Apps müssen die gleichen gesetzlichen Forderungen erfüllen wie andere Medizinprodukte. Dazu zählen die Forderungen nach Risikomanagement, Usability und Software-Lebenszyklus-Prozessen. Lernen Sie, wie Sie Ihre Medical App und Ihre Organisation auf eine "Zertifizierung" z.B. nach ISO 13485 vorbereiten können und wie Ihnen dabei Normen IEC 62304, IEC 62366 und ISO 14971 dabei helfen.
SW-Entwicklung nach IEC 62304
In Brüssel denken einige Experten darüber nach, dass nur die kritischen Komponenten von klinischen Informationssystemen konform mit den Normen (z.B. IEC 62304) entwickelt werden müssen.
Diese Präsentation ist ein Plädoyer dagegen.
Mehr von Christian Johner (12)
Medical devices: 7 steps to CE-mark, and post-market surveillance
Medical devices: 7 steps to CE-mark, and post-market surveillance
Konformitätsbewertung: In 7 Schritten zum CE-Zeichen für Ihr Medizinprodukt
Konformitätsbewertung: In 7 Schritten zum CE-Zeichen für Ihr Medizinprodukt
Konformitätsbewertung: In 7 Schritten zum CE-Zeichen für Ihr Medizinprodukt
Konformitätsbewertung: In 7 Schritten zum CE-Zeichen für Ihr Medizinprodukt
Medizinprodukte-Software: Ist QM-System notwendig?
Medizinprodukte-Software: Ist QM-System notwendig?
Mobile Medical Apps: In 5 Schritten zur "Medizinprodukte-Zertifizierung"
Mobile Medical Apps: In 5 Schritten zur "Medizinprodukte-Zertifizierung"
Zweckbestimmung von Medizinprodukten richtig formulieren
- 1. Zweckbestimmung richtigformulieren Nichtnur für MobileMedicalApps Prof. Dr. Christian Johner
- 2. Die Zweckbestimmungist entscheidend... für die Entscheidung,ob das Produkt ein Medizinprodukt ist bei der Klassifizierung des Medizin- produkts(Klassen I, IIa, IIb, III) fürs Risikomanagementnach ISO 14971 für die „Use Specification“ nach IEC 62366-1
- 3. Welche fünf Punkte eine Zweckbestimmung enthalten sollten, erfahren Sie auf den nächsten Seiten
- 4. 1.BeabsichtigtermedizinischerNutzen Welchen Krankheiten oder Verletzungen soll das Produkt (die App) dienen? Dient es der Diagnose, der Therapie, Vorhersage oder/und der Überwachung? Für welche Indikationen ist es bestimmt? Welche Kontraindikationen gelten? Wie dient es diesem Zweck?
- 5. 2.PhysikalischesPrinzip Auf welchem physikalischen Prinzip basiert es? Beispiele: Ein Röntgengerät basiert auf der gewebespezifischen Absorption von Röntgenstrahlen. Bei Apps können ggf. Algorithmen genannt werden.
- 6. Beispiele für Attribute zur Charakterisierung: Alter, Geschlecht, körperliche Einschränkungen Ausbildung, intellektuelle und sprachliche Fähigkeiten Erfahrungen auf dem Gebiet bzw. mit dem oder einem vergleichbaren Produkt 3.VorgeseheneAnwender
- 7. Beispiele für Attribute zur Charakterisierung: Demographische Angabe wie Alter und Geschlecht Allgemeinzustand Sonstige Krankheiten, Verletzungen, Komorbidität 4.Patientenpopulation
- 8. Beispiele für Attribute zur Charakterisierung physikalische Eigenschaften: Geräuschpegel, Temperatur, Feuchtigkeit, Helligkeit Arbeitsbelastung: Stress, mentaler Workload, Schichtbetrieb Aufgaben Werkzeuge, Hilfsmittel 5.Nutzungskontext
- 10. Obwohl das Produkt gemäß der (implizit oder explizit formulierten) Zweckbestimmung ein Medizinprodukt ist, hat es der Hersteller nicht als solches „zugelassen“. Verstoßgegen Gesetze
- 11. Webseite, Marketingmaterialien (Flyer, Broschüren) und die Beschreibung im AppStore widersprechen sich: Entweder das Produkt dient der Diagnose und Therapie oder nicht. InkonsistenteAussagen
- 12. Wir beantworten Ihre Fragen Stellen Ihnen Templates zur Verfügung Prüfen Ihre Zweckbestimmung Entscheiden,ob Ihr Produkt ein Medizinproduktist www.johner-institut.de/kontakt Damit Sie schnell und gesetzeskonform Ihre Produkte entwickeln und erfolgreich vermarkten! WirunterstützenSie
- 13. Einigeunserer Kunden Vom Startup bis zum Weltkonzern
- 14. Johner InstitutGmbH Villa Rheinburg Reichenaustr.1 78467 Konstanz +49 (7531) 94500-20 info@johner-institut.de www.johner-institut.de/kontakt Kostenloses Infopaket anfordern unter www.johner-institut.de MeldenSiesich!