1. Product development Engineering & Regulatory Raj Agrawal InnAccel

2. Why the process?

5. Product meets the user requirements Product is Safe & effective Regulatory compliance

6. D&D Process - Logic Requirements Design Testing Release

7. D&D Process – High level This model is translated to a more elaborated model as illustrated in the subsequent slides

8. D&D Process MRD Program Plan PRD Alpha proto D&D Plan Architecture Designs Prototypes V&V Plan User requirements Design output Clinical & regulatory Design inputs Design process Verification & internal validation M0 M0 A M0 B M1 Design Transfer & Pilot lot M2 M2 A Pilot field performance M3 Verification and validation reports Review Within each stage, the process is iterative Risk Mgt Milestones for go/ no go determination

9. Milestone-wise Deliverables User needs & program plan stage MRD Program Plan IP strategy M0 Design input stage Product reqts (PRD) Design & Development Plan Alpha proto Design review M0-A Engineering design & proto stage System Architecture, DRS, SRS, Integration Plan Prototype V&V Plan Strategy, Plan for external evaluation Preliminary Scope of external evaluation Entry Criteria for external Evaluation Design review M0-B V&V stage Verification reports Internal validation reports Readiness review for external Evaluation (based on the entry criteria) Final Scope of the external evaluation M1 Clinical & regulatory - Ready for pilot production External Evaluation outcome review Pilot customer list M2 Pilot build stage Pilot lot verification & validation results Ship first unit to customer M2-A Pilot units field performance Performance of the pilot units at customer locations Decide M4 schedule (post- market surveillance) M3

10. Proto Plan - Example

11. Proto - example Alpha proto of a secretion management device

12. High Level System Architecture- Example

13. Integrated System Architecture - Example

14. Design reviews Design Reviews are the systematic examination to – evaluate capability of the design to meet requirements evaluate adequacy of the requirements identify any problems

15. Design reviews

16. Regulatory documentation CE Product file Technical file Design output FDA Design History File (DHF) 510 (K) Device Master Record (DMR) Category DHF Elements Plan Marketing Requirement Document Product Requirement Document Design and Development Plan Verification & validation Plan Clinical Evaluation Plan Risk Management Plan System Clnical Workflow document Navigation diagram and alarm behaviour System Architecture document System Design Requirement Specification Risk management file( Risk Analysis, SHA) Residual Risk System verification protocol(SDRS) Software Software Development Plan Software Requirement Specification Software Design Specifications(SDD) Detailed Design Code Unit Test Protocols Integration test protocol Application Embedded Interface Configuration Management Review Records Mech Design Requirement Specifications -Mech Review Records Design Notes Drawings CAD Models Label Drawing Bill of Materials Hardware Design Requirement Specifications - EE Design Notes-Hardware ELECTRICAL SCHEMATIC SOP for Cable Assembly EMI EMC Changes Bill of Materials FQC(Comprises all the hardware tests ) FTR(Comprises all the hardware tests like ELECTRICAL safety Tests) Circuit Schematics PSP’s Intial Inspection Test Report Hardware Verification Test Plan Hardware Verification Test Records PCB Test Report Review Records Firmware Design Requirements Specifications - Firmware Design Notes Code Communication Protocols Unit Test Protocols Integration Test Protocols Configuration Management Review Records

17. Recap MRD Program Plan PRD Alpha proto D&D Plan Architecture Designs Prototypes V&V Plan User requirements Design output Clinical & regulatory Design inputs Design process Verification & internal validation M0 M0 A M0 B M1 Design Transfer & Pilot lot M2 M2 A Pilot field performance M3 Verification and validation reports Review Within each stage, the process is iterative Risk Mgt