13 Nov 2019 - Experts Talk: Balancing Innovation, Risks, and Compliance in Medical Device Development
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Flick through the PPT and watch a recording of Intland Software's Experts Talk webinar on 13 Nov 2019 and watch the recording at: https://intland.com/on-demand-webinar/experts-talk-balancing-innovation-risks-and-compliance-in-medical-device-development-2/
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13 Nov 2019 - Experts Talk: Balancing Innovation, Risks, and Compliance in Medical Device Development
- 1. 13/11/2019 Balancing Innovation, Risks and Compliance in Medical Device Software Development Szabolcs Agai Quality and Regulatory Expert Intland Professional Services
- 2. 2 Experts Talk Szabolcs Agai Quality and Regulatory Expert Intland Professional Services
- 3. 3 Webinar info • Q&A at the end • Access the recording at https://intland.com/webinar-recordings/ • 27 Nov 2019: Experts Talk: Integrated MedTech Delivery from Requirements through Design to Quality Documentation Sign up at https://intland.com/webinars-events/
- 4. 4 • 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
- 7. 7 Challenges Current landscape: Point solutions for Design Control Task Management Document Sharing Requirements Management QMS Documents Management Wiki MS Word
- 8. 8 Challenges Building organizational synergies: Engineering and QAR teams Engineering team Quality and regulatory team
- 9. 9 Intland Retina Integrated Application Lifecycle Management + eQMS platform 0 Medical QMS Process framework Good engineering practices
- 10. 10 Medical Software Engineering Template Process approach Validated, pre-built process templates • Medical Software Engineering • Medical Audit and CAPA management Custom tailoring • Additional and Custom Use Cases
- 11. 11 Our Medical Templates support the development of US FDA: Software as a Medical Device (SaMD) EU: Medical Device Software (MDSW)
- 12. 12 Medical Software Engineering Template Values Supports your focus on patient safety Saves time to deliver safe and effective medical devices Minimizes the effort spent on administrative tasks Enables consistent device design content for regulatory purposes
- 13. 13 Medical Software Engineering Template Key supported processes
- 14. 14 Medical Software Engineering Template Foundation • R&D Manager • Product manager • Development lead • Clinic fellow • Product risk analyst • Architect • Requirement engineer • Software developer • Verification and validation engineer • etc. • Medical software development planning • Change Management • System design and product risk management • Requirement engineering • Lifecycle product risk management • Verification and Validation • Documentation management • Software of unknown provenance management • Legacy software management • etc. • User Requirement Specification • System Requirement • System Architecture • Risk Analysis and Evaluation • Risk Control • System Product Risk Requirements/Mitigation • Software Requirements • Software Architecture • Software Design Specification • System validation protocol • SW/HW integration protocol • Software integration protocol • Software unit verification protocol • Test reports • etc. User roles Workflows Data containers
- 15. 15 Medical Software Engineering Template Foundation • R&D Manager • Product manager • Development lead • Clinic fellow • Product risk analyst • Architect • Requirement engineer • Software developer • Verification and validation engineer • etc. • Medical software development planning • Change Management • System design and product risk management • Requirement engineering • Lifecycle product risk management • Verification and Validation • Documentation management • Software of unknown provenance management • Legacy software management • etc. • User Requirement Specification • System Requirement • System Architecture • Risk Analysis and Evaluation • Risk Control • System Product Risk Requirements/Mitigation • Software Requirements • Software Architecture • Software Design Specification • System validation protocol • SW/HW integration protocol • Software integration protocol • Software unit verification protocol • Test reports • etc. User roles Workflows Data containers Preconfigured
- 16. 16 Medical Software Engineering Template Logical Data Model
- 17. 17 Medical Software Engineering Template Logical Data Model Preconfigured
- 18. 18 Medical Software Engineering Template Product Risk Management integration to Design Control
- 22. 22 Demonstration
- 23. 23 Tool Validation Validation Requirements Compliance framework
- 24. 24 • Easier definition of lifecycle-wide verification and validation processes for simplified compliance • IEC 82304, IEC 62304 (up to Class C) and ISO 14971 compliance support • Product Risk Management to analyze and evaluate risks & to maintain your Risk Management file • One-click traceability: handle all traceability issues along the product lifecycle • Integrated support and defect management • Medical Audit and CAPA Template for ISO 13485 or FDA 21 CFR Part 820-compliant QMS implementation
- 25. https://intland.com/retina/medical-device-development/ Questions? O R L E A R N M O R E A T
Notas del editor
- TODO: Keresni számokat softwares eszkozok megjelenésre How to achive that: Innovation -> Minimum measures, that still enables highly creative work Research -> More thinking on patient safety from the clinical risks prospective Development -> Applying market regulation and standardization measures -> Limited chance to market otherwise Production -> Consistency in manufacturing to preserve safety characteristics Key Challenges How to set measures that still enable the work to be accomplished for these phases How to ensure, that activities follow those measures on a timely manner How to identify and to reduce non value added activities How to still remain quick on market access/approval (--- Speciality for medical software -> production has a reduced scope (CD writing, delivering by updates, etc.) Speciality for medical software -> prone to systematic errors, if there is an error, it survives with no regard to time, does not age at all. For all medical devices -> Patient safety is first Measures in medical devices: Market regulations, (US) 21CFR820 + other CFRs by device type, (EU) MDR / IVDR Standardization, ISO62304, ISO82304, ISO14971 , ISO60601-X, etc. State of the art approaches The typical journey of medical device development (phases): From small scale innovations, To more intense researches that generates more innovations on a cyclical manner, To development that is dominated by product engineering to design medical device for mass/serial production on a reproducible, maintainable manner, To mass/serial production. ---)
- Intland -> Tooling solutions to enable medical compliance on a timely and effective manner 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 Key ones to mention: 62304, 14971 82304
- Kind of „usual” tooling to resolve medical engineering and regulatory challenges Key points: - Full traceability - Effort to keep all these up to date - Effort to keep all these integrated if possible at all - Total Cost of ownership-maintenance
- Organizational challenges Streamline cooperation of the Engineering and QAR teams Get more value out of these synergies by: Share information on a timely manner, Ensure consistency and authenticity of the information we have, Work with information rather than with data stored in office documents or in island information systems.
- 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.
- Two key implementation approach for Intland Retina Why … Custom vs Template approach
- Primary medical devices where Retina can help Template -> Pre-configured medical industry ALM solution
- Values Save time to value added activities Focus on patient safety Reduce administrative tasks Rethink the workflows you have
- Integration platform components.
- 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.
- The Retina approach is an out of the box integrated approach for Product Risk management. It includes: Integrated by design with Requirement engineering Integrated by design with taks and issue management Integrated by design with verification and validation Integrated by design with source code traceability. No need for connectors, integration work, etc., it is designed to be genuinely integrated with all components of the Template. It is part of the platform.
- From ISO14971 Key points: It is HARA driven approach, focusing on clinic risks, patient safety Common confusion, it is FMEA. FMEA is focusing on failure modes of components in the context of the next foreseeable effect. Usual suspect for focusing on FMEA: Risk assessment is retrospective, happens when the design is more or less complete. FMEA target is failure mode with next line of effect, HARA target is patient safety. Any approach could be useful, may be mixture of many like FTA, ETA, HAZOP, FMEA, etc.
- HARA key contents
- Easier compliance for Medtech oftware development (stand-alone software, software as part of an embedded system or software as a mobile medical application) in order to define the software verification and validation processes during the entire lifecycle. In General terms, the standards requirements of (IEC 82304, IEC 62304 and ISO 14971) are fulfilled. The MED SW ENG template can be tailored to the reference model according to the IEC62304 classifications, it supports only the Class C. Imrovement Areas: ISO 14971 is fully supported the Risk Management File could be created by uploaded documents. Risk analysis and evaluation is assured by the “Product Risk Management” module. One click traceability: handle all traceability issues along the product lifecycle. Integrated support and defect management is a big advantage. The Medical Audit and CAPA template efficiently support the implementation of QMS based on ISO 13485 or FDA 21 CFR Part 820.
- All process is traceable in the Template Presets provided
- Turning data to information