Understanding the requirements of the ISO 13485 standard

Home > Understanding the requirements of the ISO 13485 standard


  • Analysing and understanding the requirements of the ISO 13485:2016 standard.
  • Acquiring a sufficient skill level for deploying an operational QMS
  • Understanding the links with ISO 9001:2015 and the MDSAP programme

Audience concerned

Manufacturers/sub-contractors/distributors of MDs:
– Regulatory affairs/quality managers
– Staff with regulatory monitoring tasks
– Heads of Departments such as: Production, R&D,Purchasing, etc.
– Production, R&D and Purchasing teams


Acquiring the basics

Programme summary

  1. Introduction and objectives
  2. The ISO 13485 standard, 2016 version: analysis of all its requirements
  3. ISO 13485, 2016 version and all other standards/regulations
  4. Conclusion


  • Knowledge of quality management principles
  • Knowledge of the medical devices sector


1 day
7-hour classroom attendance


Download the registration form

Date des formations CaduCeum Academy

Ref : CAE13

Informations and registration : academy@caduceum.co.uk