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27 Nov 2019 – Experts Talk: Integrated MedTech Delivery from Requirements through Design to Quality Documentation

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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. 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
  2. 2. 2 Webinar info • Q&A at the end • Part 1 is available at: https://intland.com/experts-talk/
  3. 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. 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
  5. 5. 5 Daily ‘routine’ MedTech development Medical device design and development Time Resources Design Safety & Design Quality
  6. 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
  7. 7. 7 Intland Retina Integrated Application Lifecycle Management + eQMS platform 0 Medical QMS Process framework Good engineering practices
  8. 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. 9 Our Medical Templates support the development of US FDA: Software as a Medical Device (SaMD) EU: Medical Device Software (MDSW)
  10. 10. 10 Why Choose Intland Retina for Medical Development? Fast Implementation Audit Support Domain Experts One Template, Multiple Standards Validation Support Easy-access Approvals
  11. 11. 11 Medical Software Engineering Template Medical device design
  12. 12. 12 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
  13. 13. 13 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
  14. 14. 14 Medical Software Engineering Template Logical Data Model
  15. 15. 15 Medical Software Engineering Template Logical Data Model Preconfigured
  16. 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. 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. 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. 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. 20 Design Control New feature development – Planning and delivery management Traceability Browser Enterprise dashboards Analytics report Item status Kanban boards
  21. 21. 21 Medical Software Engineering Template DHF/RMF/TF compilation, Part 11 approvals
  22. 22. 22 Demonstration
  23. 23. 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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