Suche senden
Hochladen
Software design for_medical_devices_europe_conferent_19012011[1]
•
Als PPT, PDF herunterladen
•
5 gefällt mir
•
1,472 views
Erik Vollebregt
Folgen
Presentation at the Software Development for Medical Devices Eru
Weniger lesen
Mehr lesen
Gesundheit & Medizin
Melden
Teilen
Melden
Teilen
1 von 29
Jetzt herunterladen
Empfohlen
The regulation of software: Medicines, biologicals, blood, tissues and devices
The regulation of software: Medicines, biologicals, blood, tissues and devices
TGA Australia
Regulation of software as medical devices
Regulation of software as medical devices
TGA Australia
ISO: 14971 Quality risk management of medical devices
ISO: 14971 Quality risk management of medical devices
Atul Bhombe
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
Software as a Medical Device (SaMD) - IMDRF Definition and Categorisation
Software as a Medical Device (SaMD) - IMDRF Definition and Categorisation
pi
ISO/IEC80001 - Do we need another standard?
ISO/IEC80001 - Do we need another standard?
Robert Ginsberg
Mdcg 2019 11 guidance on qualification and classification of software mdr-ivdr
Mdcg 2019 11 guidance on qualification and classification of software mdr-ivdr
Antonio Bartolozzi
Update on software as a medical device (SaMD)
Update on software as a medical device (SaMD)
TGA Australia
Empfohlen
The regulation of software: Medicines, biologicals, blood, tissues and devices
The regulation of software: Medicines, biologicals, blood, tissues and devices
TGA Australia
Regulation of software as medical devices
Regulation of software as medical devices
TGA Australia
ISO: 14971 Quality risk management of medical devices
ISO: 14971 Quality risk management of medical devices
Atul Bhombe
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
Software as a Medical Device (SaMD) - IMDRF Definition and Categorisation
Software as a Medical Device (SaMD) - IMDRF Definition and Categorisation
pi
ISO/IEC80001 - Do we need another standard?
ISO/IEC80001 - Do we need another standard?
Robert Ginsberg
Mdcg 2019 11 guidance on qualification and classification of software mdr-ivdr
Mdcg 2019 11 guidance on qualification and classification of software mdr-ivdr
Antonio Bartolozzi
Update on software as a medical device (SaMD)
Update on software as a medical device (SaMD)
TGA Australia
IEC 62304: SDLC Conformance and Management
IEC 62304: SDLC Conformance and Management
MethodSense, Inc.
FDA Regulations and Medical Device Pathways to Market
FDA Regulations and Medical Device Pathways to Market
MethodSense, Inc.
mdcg 2019 11 Decision steps for qualification of software as MDSW
mdcg 2019 11 Decision steps for qualification of software as MDSW
Antonio Bartolozzi
QAdvis - software risk management based on IEC/ISO 62304
QAdvis - software risk management based on IEC/ISO 62304
Robert Ginsberg
An Overview for Software as a Medical Device (SaMD)
An Overview for Software as a Medical Device (SaMD)
DePuy Synthes
Medical Device Software
Medical Device Software
heilbrigdisidnadurinn
2011 raps presentation subcontractors software social media fox rev 2
2011 raps presentation subcontractors software social media fox rev 2
Erik Vollebregt
IEC 62304 Action List
IEC 62304 Action List
MethodSense, Inc.
Medical device design guidlines
Medical device design guidlines
Suhas R
Human factors and ergonomics society 20120311
Human factors and ergonomics society 20120311
Jones Wu
Risk Management in Medical Device Development
Risk Management in Medical Device Development
Intland Software GmbH
Computer System Validation is not mere testing
Computer System Validation is not mere testing
Anand Rao. C
Iso 14971 2019
Iso 14971 2019
Suhas R
Requirements of clinical evaluation report for medical devices
Requirements of clinical evaluation report for medical devices
MakroCare Clinical Research Limited
CSV - Computer System Validation
CSV - Computer System Validation
JayaKrishna161
Risk Management Research 2016
Risk Management Research 2016
Niamh Lynch
Understanding IEC 62304
Understanding IEC 62304
MethodSense, Inc.
Abbott overview medical device human factors standards
Abbott overview medical device human factors standards
Jones Wu
Clinical investigations - Intended Normal condition of use
Clinical investigations - Intended Normal condition of use
Antonio Bartolozzi
mHealth Israel_Digital Health_The Regulatory Landscape 2017
mHealth Israel_Digital Health_The Regulatory Landscape 2017
Levi Shapiro
Presentation: Proposed Reforms to the Regulation of Software, Including Softw...
Presentation: Proposed Reforms to the Regulation of Software, Including Softw...
TGA Australia
EU Medical Device Directive Newcastle May
EU Medical Device Directive Newcastle May
HANDI HEALTH
Weitere ähnliche Inhalte
Was ist angesagt?
IEC 62304: SDLC Conformance and Management
IEC 62304: SDLC Conformance and Management
MethodSense, Inc.
FDA Regulations and Medical Device Pathways to Market
FDA Regulations and Medical Device Pathways to Market
MethodSense, Inc.
mdcg 2019 11 Decision steps for qualification of software as MDSW
mdcg 2019 11 Decision steps for qualification of software as MDSW
Antonio Bartolozzi
QAdvis - software risk management based on IEC/ISO 62304
QAdvis - software risk management based on IEC/ISO 62304
Robert Ginsberg
An Overview for Software as a Medical Device (SaMD)
An Overview for Software as a Medical Device (SaMD)
DePuy Synthes
Medical Device Software
Medical Device Software
heilbrigdisidnadurinn
2011 raps presentation subcontractors software social media fox rev 2
2011 raps presentation subcontractors software social media fox rev 2
Erik Vollebregt
IEC 62304 Action List
IEC 62304 Action List
MethodSense, Inc.
Medical device design guidlines
Medical device design guidlines
Suhas R
Human factors and ergonomics society 20120311
Human factors and ergonomics society 20120311
Jones Wu
Risk Management in Medical Device Development
Risk Management in Medical Device Development
Intland Software GmbH
Computer System Validation is not mere testing
Computer System Validation is not mere testing
Anand Rao. C
Iso 14971 2019
Iso 14971 2019
Suhas R
Requirements of clinical evaluation report for medical devices
Requirements of clinical evaluation report for medical devices
MakroCare Clinical Research Limited
CSV - Computer System Validation
CSV - Computer System Validation
JayaKrishna161
Risk Management Research 2016
Risk Management Research 2016
Niamh Lynch
Understanding IEC 62304
Understanding IEC 62304
MethodSense, Inc.
Abbott overview medical device human factors standards
Abbott overview medical device human factors standards
Jones Wu
Clinical investigations - Intended Normal condition of use
Clinical investigations - Intended Normal condition of use
Antonio Bartolozzi
Was ist angesagt?
(19)
IEC 62304: SDLC Conformance and Management
IEC 62304: SDLC Conformance and Management
FDA Regulations and Medical Device Pathways to Market
FDA Regulations and Medical Device Pathways to Market
mdcg 2019 11 Decision steps for qualification of software as MDSW
mdcg 2019 11 Decision steps for qualification of software as MDSW
QAdvis - software risk management based on IEC/ISO 62304
QAdvis - software risk management based on IEC/ISO 62304
An Overview for Software as a Medical Device (SaMD)
An Overview for Software as a Medical Device (SaMD)
Medical Device Software
Medical Device Software
2011 raps presentation subcontractors software social media fox rev 2
2011 raps presentation subcontractors software social media fox rev 2
IEC 62304 Action List
IEC 62304 Action List
Medical device design guidlines
Medical device design guidlines
Human factors and ergonomics society 20120311
Human factors and ergonomics society 20120311
Risk Management in Medical Device Development
Risk Management in Medical Device Development
Computer System Validation is not mere testing
Computer System Validation is not mere testing
Iso 14971 2019
Iso 14971 2019
Requirements of clinical evaluation report for medical devices
Requirements of clinical evaluation report for medical devices
CSV - Computer System Validation
CSV - Computer System Validation
Risk Management Research 2016
Risk Management Research 2016
Understanding IEC 62304
Understanding IEC 62304
Abbott overview medical device human factors standards
Abbott overview medical device human factors standards
Clinical investigations - Intended Normal condition of use
Clinical investigations - Intended Normal condition of use
Ähnlich wie Software design for_medical_devices_europe_conferent_19012011[1]
mHealth Israel_Digital Health_The Regulatory Landscape 2017
mHealth Israel_Digital Health_The Regulatory Landscape 2017
Levi Shapiro
Presentation: Proposed Reforms to the Regulation of Software, Including Softw...
Presentation: Proposed Reforms to the Regulation of Software, Including Softw...
TGA Australia
EU Medical Device Directive Newcastle May
EU Medical Device Directive Newcastle May
HANDI HEALTH
Software As Device - Frank Maxwell
Software As Device - Frank Maxwell
healthcareisi
Critical Steps in Software Development: Enhance Your Chances for a Successful...
Critical Steps in Software Development: Enhance Your Chances for a Successful...
Sterling Medical Devices
The critical role of QA in Medical Device Testing.pdf
The critical role of QA in Medical Device Testing.pdf
Mindfire LLC
TGA webinar presentation: Regulation of software, including software as a med...
TGA webinar presentation: Regulation of software, including software as a med...
TGA Australia
Medical Device Software Development: Key Processes and Critical Factors
Medical Device Software Development: Key Processes and Critical Factors
DashTechnologiesInc
MHRA - 18th March 2014
MHRA - 18th March 2014
Anthony A Hill
Presentation: The challenges of regulating direct to consumer digital medical...
Presentation: The challenges of regulating direct to consumer digital medical...
TGA Australia
The challenges of regulating direct to consumer digital medical devices
The challenges of regulating direct to consumer digital medical devices
TGA Australia
Medical software – us regulation
Medical software – us regulation
heilbrigdisidnadurinn
Post Marketing Surveillance - RSI
Post Marketing Surveillance - RSI
Regulatory Solutions India
Update on software as a medical device (SaMD)
Update on software as a medical device (SaMD)
TGA Australia
Software Validation for Medical Devices
Software Validation for Medical Devices
EMMAIntl
Advamed MDR IVDR update
Advamed MDR IVDR update
Erik Vollebregt
TwinSPIN_Lecture.ppt
TwinSPIN_Lecture.ppt
Vineedh Mathew
clinical-evaluation-report (CER)
clinical-evaluation-report (CER)
PEPGRA Healthcare
Clinical evaluation report cer in a more stringent regulatory- Pepgra Healthcare
Clinical evaluation report cer in a more stringent regulatory- Pepgra Healthcare
PEPGRA Healthcare
Webinar: Europe's new Medical Device Regulations (MDR)
Webinar: Europe's new Medical Device Regulations (MDR)
EMERGO
Ähnlich wie Software design for_medical_devices_europe_conferent_19012011[1]
(20)
mHealth Israel_Digital Health_The Regulatory Landscape 2017
mHealth Israel_Digital Health_The Regulatory Landscape 2017
Presentation: Proposed Reforms to the Regulation of Software, Including Softw...
Presentation: Proposed Reforms to the Regulation of Software, Including Softw...
EU Medical Device Directive Newcastle May
EU Medical Device Directive Newcastle May
Software As Device - Frank Maxwell
Software As Device - Frank Maxwell
Critical Steps in Software Development: Enhance Your Chances for a Successful...
Critical Steps in Software Development: Enhance Your Chances for a Successful...
The critical role of QA in Medical Device Testing.pdf
The critical role of QA in Medical Device Testing.pdf
TGA webinar presentation: Regulation of software, including software as a med...
TGA webinar presentation: Regulation of software, including software as a med...
Medical Device Software Development: Key Processes and Critical Factors
Medical Device Software Development: Key Processes and Critical Factors
MHRA - 18th March 2014
MHRA - 18th March 2014
Presentation: The challenges of regulating direct to consumer digital medical...
Presentation: The challenges of regulating direct to consumer digital medical...
The challenges of regulating direct to consumer digital medical devices
The challenges of regulating direct to consumer digital medical devices
Medical software – us regulation
Medical software – us regulation
Post Marketing Surveillance - RSI
Post Marketing Surveillance - RSI
Update on software as a medical device (SaMD)
Update on software as a medical device (SaMD)
Software Validation for Medical Devices
Software Validation for Medical Devices
Advamed MDR IVDR update
Advamed MDR IVDR update
TwinSPIN_Lecture.ppt
TwinSPIN_Lecture.ppt
clinical-evaluation-report (CER)
clinical-evaluation-report (CER)
Clinical evaluation report cer in a more stringent regulatory- Pepgra Healthcare
Clinical evaluation report cer in a more stringent regulatory- Pepgra Healthcare
Webinar: Europe's new Medical Device Regulations (MDR)
Webinar: Europe's new Medical Device Regulations (MDR)
Mehr von Erik Vollebregt
Economic operators and the exits
Economic operators and the exits
Erik Vollebregt
Q1 medical device packaging conference 10 november 2020
Q1 medical device packaging conference 10 november 2020
Erik Vollebregt
Easy medical devices podcast self tests ivdr
Easy medical devices podcast self tests ivdr
Erik Vollebregt
Your legal relationship with your notified body
Your legal relationship with your notified body
Erik Vollebregt
Point of-care, biosensors & mobile diagnostics europe 2019
Point of-care, biosensors & mobile diagnostics europe 2019
Erik Vollebregt
HOW TO WORK WITH EMERGENCY RULES RELATING TO COVID 19?
HOW TO WORK WITH EMERGENCY RULES RELATING TO COVID 19?
Erik Vollebregt
M&A and medical devices presentation
M&A and medical devices presentation
Erik Vollebregt
MDR and class I medical devices presentation
MDR and class I medical devices presentation
Erik Vollebregt
Q1 MDR and IVDR PRRC presentation
Q1 MDR and IVDR PRRC presentation
Erik Vollebregt
Legal aspects of the new EU Medical Devices Regulation - known and unknowns
Legal aspects of the new EU Medical Devices Regulation - known and unknowns
Erik Vollebregt
Advamed Med Tech 2019 countdown presentation
Advamed Med Tech 2019 countdown presentation
Erik Vollebregt
Managing New Requirement for Economic Operator Regime
Managing New Requirement for Economic Operator Regime
Erik Vollebregt
Legal and regulatory developments in precision medicine and diagnostic devices
Legal and regulatory developments in precision medicine and diagnostic devices
Erik Vollebregt
Q1 Medical Devices Regulation - practical consequences for manufacturers
Q1 Medical Devices Regulation - practical consequences for manufacturers
Erik Vollebregt
Economic operators under the MDR and IVDR
Economic operators under the MDR and IVDR
Erik Vollebregt
GDPR and eHealth for the pharma industry (VFenR presentation)
GDPR and eHealth for the pharma industry (VFenR presentation)
Erik Vollebregt
VZI jaarcongres: de MDR en IVDR - de impact in de medische techniek
VZI jaarcongres: de MDR en IVDR - de impact in de medische techniek
Erik Vollebregt
NEN symposium on Medical Devices and IVD Regulation
NEN symposium on Medical Devices and IVD Regulation
Erik Vollebregt
Advamed EU MDR and IVDR panel presentation
Advamed EU MDR and IVDR panel presentation
Erik Vollebregt
Use of left over samples under the IVDR and GDPR
Use of left over samples under the IVDR and GDPR
Erik Vollebregt
Mehr von Erik Vollebregt
(20)
Economic operators and the exits
Economic operators and the exits
Q1 medical device packaging conference 10 november 2020
Q1 medical device packaging conference 10 november 2020
Easy medical devices podcast self tests ivdr
Easy medical devices podcast self tests ivdr
Your legal relationship with your notified body
Your legal relationship with your notified body
Point of-care, biosensors & mobile diagnostics europe 2019
Point of-care, biosensors & mobile diagnostics europe 2019
HOW TO WORK WITH EMERGENCY RULES RELATING TO COVID 19?
HOW TO WORK WITH EMERGENCY RULES RELATING TO COVID 19?
M&A and medical devices presentation
M&A and medical devices presentation
MDR and class I medical devices presentation
MDR and class I medical devices presentation
Q1 MDR and IVDR PRRC presentation
Q1 MDR and IVDR PRRC presentation
Legal aspects of the new EU Medical Devices Regulation - known and unknowns
Legal aspects of the new EU Medical Devices Regulation - known and unknowns
Advamed Med Tech 2019 countdown presentation
Advamed Med Tech 2019 countdown presentation
Managing New Requirement for Economic Operator Regime
Managing New Requirement for Economic Operator Regime
Legal and regulatory developments in precision medicine and diagnostic devices
Legal and regulatory developments in precision medicine and diagnostic devices
Q1 Medical Devices Regulation - practical consequences for manufacturers
Q1 Medical Devices Regulation - practical consequences for manufacturers
Economic operators under the MDR and IVDR
Economic operators under the MDR and IVDR
GDPR and eHealth for the pharma industry (VFenR presentation)
GDPR and eHealth for the pharma industry (VFenR presentation)
VZI jaarcongres: de MDR en IVDR - de impact in de medische techniek
VZI jaarcongres: de MDR en IVDR - de impact in de medische techniek
NEN symposium on Medical Devices and IVD Regulation
NEN symposium on Medical Devices and IVD Regulation
Advamed EU MDR and IVDR panel presentation
Advamed EU MDR and IVDR panel presentation
Use of left over samples under the IVDR and GDPR
Use of left over samples under the IVDR and GDPR
Kürzlich hochgeladen
Let's Talk About It: To Disclose or Not to Disclose?
Let's Talk About It: To Disclose or Not to Disclose?
bkling
Pharmaceutical Marketting: Unit-5, Pricing
Pharmaceutical Marketting: Unit-5, Pricing
Arunagarwal328757
Culture and Health Disorders Social change.pptx
Culture and Health Disorders Social change.pptx
Dr. Dheeraj Kumar
Wessex Health Partners Wessex Integrated Care, Population Health, Research & ...
Wessex Health Partners Wessex Integrated Care, Population Health, Research & ...
Wessex Health Partners
Lippincott Microcards_ Microbiology Flash Cards-LWW (2015).pdf
Lippincott Microcards_ Microbiology Flash Cards-LWW (2015).pdf
Sreeja Cherukuru
call girls in green park DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️
call girls in green park DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️
saminamagar
METHODS OF ACQUIRING KNOWLEDGE IN NURSING.pptx by navdeep kaur
METHODS OF ACQUIRING KNOWLEDGE IN NURSING.pptx by navdeep kaur
Navdeep Kaur
COVID-19 (NOVEL CORONA VIRUS DISEASE PANDEMIC ).pptx
COVID-19 (NOVEL CORONA VIRUS DISEASE PANDEMIC ).pptx
Bibekananda shah
Primary headache and facial pain. (2024)
Primary headache and facial pain. (2024)
Mohamed Rizk Khodair
call girls in aerocity DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️
call girls in aerocity DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️
saminamagar
Big Data Analysis Suggests COVID Vaccination Increases Excess Mortality Of ...
Big Data Analysis Suggests COVID Vaccination Increases Excess Mortality Of ...
sdateam0
call girls in Dwarka Sector 21 Metro DELHI 🔝 >༒9540349809 🔝 genuine Escort Se...
call girls in Dwarka Sector 21 Metro DELHI 🔝 >༒9540349809 🔝 genuine Escort Se...
saminamagar
PNEUMOTHORAX AND ITS MANAGEMENTS.pdf
PNEUMOTHORAX AND ITS MANAGEMENTS.pdf
Dolisha Warbi
call girls in munirka DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️
call girls in munirka DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️
saminamagar
PULMONARY EDEMA AND ITS MANAGEMENT.pdf
PULMONARY EDEMA AND ITS MANAGEMENT.pdf
Dolisha Warbi
Radiation Dosimetry Parameters and Isodose Curves.pptx
Radiation Dosimetry Parameters and Isodose Curves.pptx
Dr. Dheeraj Kumar
Informed Consent Empowering Healthcare Decision-Making.pptx
Informed Consent Empowering Healthcare Decision-Making.pptx
SasikiranMarri
world health day presentation ppt download
world health day presentation ppt download
AnkitKumar311566
Report Back from SGO: What’s New in Uterine Cancer?.pptx
Report Back from SGO: What’s New in Uterine Cancer?.pptx
bkling
Statistical modeling in pharmaceutical research and development.
Statistical modeling in pharmaceutical research and development.
ANJALI
Kürzlich hochgeladen
(20)
Let's Talk About It: To Disclose or Not to Disclose?
Let's Talk About It: To Disclose or Not to Disclose?
Pharmaceutical Marketting: Unit-5, Pricing
Pharmaceutical Marketting: Unit-5, Pricing
Culture and Health Disorders Social change.pptx
Culture and Health Disorders Social change.pptx
Wessex Health Partners Wessex Integrated Care, Population Health, Research & ...
Wessex Health Partners Wessex Integrated Care, Population Health, Research & ...
Lippincott Microcards_ Microbiology Flash Cards-LWW (2015).pdf
Lippincott Microcards_ Microbiology Flash Cards-LWW (2015).pdf
call girls in green park DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️
call girls in green park DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️
METHODS OF ACQUIRING KNOWLEDGE IN NURSING.pptx by navdeep kaur
METHODS OF ACQUIRING KNOWLEDGE IN NURSING.pptx by navdeep kaur
COVID-19 (NOVEL CORONA VIRUS DISEASE PANDEMIC ).pptx
COVID-19 (NOVEL CORONA VIRUS DISEASE PANDEMIC ).pptx
Primary headache and facial pain. (2024)
Primary headache and facial pain. (2024)
call girls in aerocity DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️
call girls in aerocity DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️
Big Data Analysis Suggests COVID Vaccination Increases Excess Mortality Of ...
Big Data Analysis Suggests COVID Vaccination Increases Excess Mortality Of ...
call girls in Dwarka Sector 21 Metro DELHI 🔝 >༒9540349809 🔝 genuine Escort Se...
call girls in Dwarka Sector 21 Metro DELHI 🔝 >༒9540349809 🔝 genuine Escort Se...
PNEUMOTHORAX AND ITS MANAGEMENTS.pdf
PNEUMOTHORAX AND ITS MANAGEMENTS.pdf
call girls in munirka DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️
call girls in munirka DELHI 🔝 >༒9540349809 🔝 genuine Escort Service 🔝✔️✔️
PULMONARY EDEMA AND ITS MANAGEMENT.pdf
PULMONARY EDEMA AND ITS MANAGEMENT.pdf
Radiation Dosimetry Parameters and Isodose Curves.pptx
Radiation Dosimetry Parameters and Isodose Curves.pptx
Informed Consent Empowering Healthcare Decision-Making.pptx
Informed Consent Empowering Healthcare Decision-Making.pptx
world health day presentation ppt download
world health day presentation ppt download
Report Back from SGO: What’s New in Uterine Cancer?.pptx
Report Back from SGO: What’s New in Uterine Cancer?.pptx
Statistical modeling in pharmaceutical research and development.
Statistical modeling in pharmaceutical research and development.
Software design for_medical_devices_europe_conferent_19012011[1]
1.
Legal aspects of
medical devices software and software as medical device 19 January 2011 ©2007, Greenberg Traurig, LLP. Attorneys at Law. All rights reserved. GREENBERG TRAURIG, LLP ▪ ATTORNEYS AT LAW ▪ WWW.GTLAW.COM Software Design for Medical Devices EUROPE
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
IEC 62304 -
Relationship to other standards
21.
22.
23.
24.
25.
26.
27.
28.
29.
Jetzt herunterladen