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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. 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. 2 Experts Talk Szabolcs Agai Quality and Regulatory Expert Intland Professional Services
  3. 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. 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
  5. 5. 5 Balancing measures Innovation Research Development Production
  6. 6. 6 Compliance Challenges
  7. 7. 7 Challenges Current landscape: Point solutions for Design Control Task Management Document Sharing Requirements Management QMS Documents Management Wiki MS Word
  8. 8. 8 Challenges Building organizational synergies: Engineering and QAR teams Engineering team Quality and regulatory team
  9. 9. 9 Intland Retina Integrated Application Lifecycle Management + eQMS platform 0 Medical QMS Process framework Good engineering practices
  10. 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. 11 Our Medical Templates support the development of US FDA: Software as a Medical Device (SaMD) EU: Medical Device Software (MDSW)
  12. 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. 13 Medical Software Engineering Template Key supported processes
  14. 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. 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. 16 Medical Software Engineering Template Logical Data Model
  17. 17. 17 Medical Software Engineering Template Logical Data Model Preconfigured
  18. 18. 18 Medical Software Engineering Template Product Risk Management integration to Design Control
  19. 19. 19 Product Risk Management
  20. 20. 20 Demonstration Product Risk Management
  21. 21. 21 Demonstration Product Risk Management
  22. 22. 22 Demonstration
  23. 23. 23 Tool Validation Validation Requirements Compliance framework
  24. 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. 25. https://intland.com/retina/medical-device-development/ Questions? O R L E A R N M O R E A T

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