Medical Device Design Projects (ANVISA, FDA and CE/MDR)

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01

Course description

40-hour specialist training in two parts (Design Fundamentals, 16 hours, and Advanced Design Management, 24 hours), covering Design Controls, risk management, usability, biocompatibility, clinical evaluation, verification and validation (V&V), and complete technical documentation (DHF, DMR, DHR) under ANVISA, FDA (QMSR), CE/MDR and MDSAP. Includes an integrated project with multi-jurisdictional submission.

02

Course objective

Equip participants to conduct medical device design and development under Design Controls, integrating risk management, usability, verification and validation (V&V), and complete technical documentation (DHF, DMR, DHR) to meet ANVISA, FDA (QMSR), CE/MDR and MDSAP requirements simultaneously.

03

Course programme

  1. 01

    Design Fundamentals (16 hours)

  2. 02

    Advanced Design Management (24 hours)

  3. 03

    Design Controls: design input, output, review and transfer

  4. 04

    Risk management (ISO 14971) and usability engineering (IEC 62366)

  5. 05

    Biocompatibility (ISO 10993) and clinical evaluation

  6. 06

    Verification and validation (V&V) and traceability

  7. 07

    Technical documentation: DHF, DMR and DHR

  8. 08

    Multi-jurisdictional submission (ANVISA, FDA/QMSR, CE/MDR and MDSAP) and an integrated project

04

Who can attend?

  • R&D and Design engineers, Regulatory Affairs, Quality and Compliance professionals, regulatory consultants and professionals moving into the medical device sector.