Design Management for Medical Devices (MDSAP/MDR 745/ISO 13485:2016 and RDC 665/22)

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01

Course description

A course on the practical application of ISO 13485:2016 and RDC 665/2022 requirements to planning, controlling and documenting medical device design and development, structuring the Design History File (DHF) as expected by national and international regulatory authorities.

02

Course objective

Prepare participants to manage medical device development projects in accordance with Good Manufacturing Practice, structuring the technical documentation required by ANVISA, FDA and European notified bodies.

03

Course programme

16h of in-depth learning
  1. 01

    ISO 13485:2016 Clause 7.3, Design and Development

  2. 02

    Applicable RDC 665/2022 requirements

  3. 03

    Design planning and multidisciplinary interfaces

  4. 04

    Inputs, outputs, review, verification and validation

  5. 05

    Design transfer to production

  6. 06

    Design change control

  7. 07

    Structuring the Design History File (DHF)

04

Who can attend?

  • Product engineers, Research & Development (R&D), Quality and Regulatory Affairs professionals, Project Managers and teams involved in medical device development.

Certification

HSC Global Certificate