Flick through the PPT and watch a recording of Intland Software's Experts Talk webinar on 27 Nov 2019 and watch the recording at https://intland.com/on-demand-webinar/experts-talk-integrated-medtech-delivery-from-requirements-through-design-to-quality-documentation-2/
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27 Nov 2019 – Experts Talk: Integrated MedTech Delivery from Requirements through Design to Quality Documentation
1. 27/11/2019
Integrated MedTech Delivery
from Requirements through Design
to Quality Documentation
Szabolcs Agai
Quality and Regulatory Expert
Intland Professional Services
László Katona
Field Application Engineer
Intland Software
3. 3
• Company founded in 1998,
HQ in Stuttgart, Germany
• Active in safety-critical markets
for over 10 years
• Products and processes
certified by TÜV Nord and TÜV Süd
Who we are
Intland Software &
Medical Device Developers
4. 4
Regulatory environment
MedTech development
Market regulations
Harmonized, recognized standards
Manufacturer’s QMS Customer’s QMS Engineering practices
Market / Customer
expectations
Organizational
goals
Medical device
design and development
6. 6
MedTech development
Daily challenges
• How to keep delivery targets?
• How to deliver concise contents for DHK/TF?
• How to effectively manage resources?
• Product development
• Certification & Validation
• Configuration management
• Change management
• Many others
Processes
• Design control
• Product risk management
• Project management
• Porduct line management
• Auditing
Artifacts / contents
• Management reporting
• Regulatory reporting
• Many others
Medical device
design and development
8. 8
What is a Project Template?
Project with preconfigured Trackers, Workflows, Reports, and Dashboards
• Goal: Reduce implementation effort by 80%
• Customize further with Professional Services support
9. 9
Our Medical Templates
support the development of
US FDA:
Software as a Medical Device (SaMD)
EU:
Medical Device Software (MDSW)
10. 10
Why Choose Intland Retina for Medical Development?
Fast Implementation Audit Support Domain Experts
One Template,
Multiple Standards
Validation Support
Easy-access
Approvals
16. 16
Design Control
New feature development
I have an idea
for a new
feature
1. User Requirement
Specification
2. Change Request
1. Planning tasks
2. Planning deliverables
3. Planning time &
resources
17. 17
Design Control
New feature development - Deliverables
a) Mechanical, hardware &
software device
b) Hardware + Software
c) Software „only”
Clinically safe design
a) Documentation for users
b) Documentation for
regulators
Contents for market clearance
18. 18
Design Control
New feature development – Planning and delivery management
• CR 1
• CR 2
• CR 3
Change
Requests
• T1
• T3
• T5
Tasks
• T2
• T4
• T6
Development Phase 1 Phase 2 ... Phase n
• T1
• T3
• T2
• T4
• T5 • T6
(not scheduled)
CR2, CR3
19. 19
Design Control
New feature development – Planning and delivery management
Status of clinically safe design
Status of device design
Status of deliverables for market
clearance
Task
completeness
20. 20
Design Control
New feature development – Planning and delivery management
Traceability
Browser
Enterprise
dashboards
Analytics report
Item status
Kanban boards
Poll
1., Is your market clearance related contents ready by the time the device design completed?
- Regulatory submission contents ready prior engineering finishes the design
- Regulatory and engineering contents are ready almost at the same time
- Regulatory submission contents mostly delay beyond the time whe
Medical device development is a special in a sense that it works in a rather regulated environment.
Requirements for market access are set in multiple layers
There are the following:
Market regulators -> US FDA, EU, Health Canada, etc.
Market regulations -> 21 CFR 807, EU MDR/IUDR, etc.
Harmonized, recognized standards -> IEC 60601-x, ISO 62304, ISO 82304, ISO 14971, etc.
Quality managemen systems for the design organization
May be the part of the Quality managemen systems for the Customers
Also, Engineering practices that is from the design entity experience
Standardization Landscape for medical software engineering
Generic safety standard
61508
Generic IT and software engineering standards
12207, 90003
Generic Medical process standards
13485, 14971
Med and Health SW specific process standards
62304, 82304
62366
Electric MED Product standards
60601-x
Electric equipment for measurements, control and laboratory use
61010, 61010-x
STORY kell!!
Design organization day to day challenges
1., Time constrains
From the Organization itself -> timing of product roadmaps
From key Customers -> feature expectations on a timely manner
From Market Regulators -> Design contents for market clearances
2., Resource constrains
Project that is planned for 6 engineers for a year cannot be accomplished in a month by 72 engineers
Keeping team motivated
Providing sensible, value added activities
Minimize unnecessary administrative work -> Help to preserve employee retention
3., Balancing Safety and Quality
One end of the scale:
Fully and perfectly safe device does little to nothing from functionality prospective. -> Safe, but not viable from marketing prospective
Other end of this scale:
Ignored safety for the device that is actually rich in functionality -> Attractive on the market, patient safety however compromised
Design framework for MedTech companies
1., Best in class, compliant process framework
2., Extended contents for the deliverables. Design contents for regulatory purposes is a must.
How does it approached …
One end of the scale
Dedicated technical and regulatory documentation team is dealing with all the market clearance contents.
Tipically after design completed.
Other end of the scale
Nothing is implemented unless the mandatary design contents are ready.
Probably not any of these are practical.
Mid-way out of this challenge -> Incorporate regulatory requirements in the early design phases, and carry on with these through product desing and development.
Result could be -> Design readiness will correspond to regulatory clearance readiness for the design.
Poll:
2., What are the key challenges for your design organization?
- Ensure and maintain safe device design
- Manage resources for engineering activities
- Maintain consistency for device characteristics
- Go to market on a timely manner
- None of the above
Merging practises to common platform.
We have a NEW tool solution for all of these, called Intland Retina.
It is new common, integrated, easily accessible ALM platform with eQMS capabilities.
All software development teams in all key industries can benefit from Intland Retina.
To serve the needs of the Medical Device Software developers facing regulatory challenges, we have created process templates.
The project template contains configuration based on a Data models. These UML models have been created based on the requirements of regulatory standards.
This image shows the main areas that our templates are dedicated for, and their connections points.
Primary medical devices where Retina can help
Template -> Pre-configured medical industry ALM solution
This slide focuses on the values and benefits of using Intland Retina and its medical templates.
Fast Implementation: Intland has invested the time and effort to develop project templates according to standard requirements, so you won’t have to. Plus the new UI is intuitive, meaning it requires less training, so rollout is quick and smooth.
Audit Support: Intland Retina is strong in both design control and QMS features. End-to-end traceability is ensured and is easy to query. Customized reports may be simply created, and approved in one click.
Domain Experts: Intland has outstanding domain experts in-house to contribute to the development and maintenance of our solutions and templates.
One Template, Multiple Standards: Medical is a highly regulated industry where many standards may be applicable to a single product. With our 2 medical templates, we support 6 regulatory standards and the successful completion of compliance audits.
Validation Support: Intland Retina powered by codeBeamer is TÜV Nord-certified Trusted Tool. Our templates are validated by industry experts. We offer a Validation Kit with almost 800 requirements and test cases to support tool qualification processes and to cut the costs of validating your software tools.
Easy-access Approvals: Both the tool and our template offer easy access for Reviewers involved in the approval process. Using our solutions, they can accept and approve documents and reports with timestamped e-signatures that are displayed in a human readable format as per regulatory requirements.
The Template intends to support medtech delivery processes end to end. Starting with the medical system’s design, it supports risk management (risk assessment and control). It also supports the design of both hardware and software subsystems. The Template comes configured to support Validation and Verification (testing)processes. Support for all additional requirements is buillt in such as the management of source code or housing needed for implemetation.
How do we do it.
Key aspects to design ALM application.
Can be done by user customization, can be by the Template or by the modification of the template.
Core integration to Product Risk Management.
Information containers,
Can be done by user customization, can be by the Template or by the modification of the template.
Before the product demonstration, let go through quickly the workflow we will see.
New feature development
Step 0 ->
Customer, Product Management, Product Risk Management, Marketing has a new idea for a feature for an existing product.
Step 1->
URS created together with Engineering
Change Request discusses from timing, resourcing, budgeting and impact analysis prospective
Step2
Planning for release -> Task management planning
Medical device design has some special characteristics
Deliverables management is one of these.
Deliverables for software devices are not limited to binaries and user manuals.
Design contents are key parts for market clearances.
Two key part of deliverables:
1., The design itself
2., Design, development, verification and validation contents for users and for regulators
One roadmap milestone may include a single, or multiple change requests.
Change requests are elaborated on task levels
References, relationships of Change requests and tasks is a must to manage product development effectively.
Development phases varies from one company to another.
Phases can be set for V model or Agile kind of development processes.
IEC62304 or IEC82304 process phases are also can be easily set in the Template if applicable.
Change request sets relates to roadmap milestones.
Tasks are assigned to a single phase or to multiple phases for activity tracking.
Tasks for design content compilation and completion can be set here and assigned to the corresponding development phase.
It could be tasks for:
System requirement compilation,
Product Risk Management activity delivery,
Verification protocol and verification activity completion,
Etcetera.
Artifacts to these tasks also can be assigned if needed by customization.
Tasks also a workflow on itsown, that workflow is pre-configured.
Managing tasks with workflows enable to evaluate either automatically or by manually the status of corresponding tasks or artifacts.
Criteria could be:
1., Is the product risk related activities and/or artifacts are complited already
2., What is the design phase where we are in
3., Readiness of the key market clearance deliverables (URS, SRS, SDD, etc.)
Poll 3 :
What is the most resource intense area of your device design activities
- System design
- Product risk management
- Implementation
- Verification
- Clinic validation
- Regulatory submissions
- None of the above
Built in, default system tool to gain further confidence of tasks, change requests, artifacts statuses.
1., On-lin traceability browser
2., Reports from analytics, on-line reporting system
3., Kanban boards for all item types
4., Customizable, however pre-configured, role-based dashboards
This picture shows the information flow via documents. An imported document can be, for example, the requirements of a new device, or change requests for its new version. That document can be imported and further managed across Design Control, Risk Management, and Verification. Data storage trackers allow you to export data to documents, which can then be approved using the Review Hub. The Review Hub allows users to review (approve, reject, and comment on) documents with multiple reviewers using e-signature functionality. After review, the status of those documents may be set to approved, and could serve as input for Regulatory Reporting documents. Those files can be collected and stored in the Template’s Document Control area as Design History Files, Risk Management, or Test Files.
Szaby:
Document export process flow from internal information container to office document.
Also, suitable to import contents from office documents into the Template.
Importing happens once for the preconfigured information containers, than contents, like System/subsystem/Design requirements, architectures, references, test protocols,
managed in Intland Retina.
One exception is the documentation containers, like DHF, RMF, etc, where documents are managed as a documentation management system.
Part11 signatures can be applied if needed for any workflow steps.