- 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
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
- Introduction and objectives
- The ISO 13485 standard, 2016 version: analysis of all its requirements
- ISO 13485, 2016 version and all other standards/regulations
- Knowledge of quality management principles
- Knowledge of the medical devices sector
7-hour classroom attendance