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The harmonised EN ISO 13485:2016 standard can be used to show compliance with the regulations and constitutional requirements needed for companies supplying medical devices and associated services in the EU. By implementing a quality management system according to this standard, you fulfil many applicable sections of the Medical Device Directive (MDD 93/42/EEC) and are well prepared for both Medical Device Regulation (MDR 2017/745) and (IVDR 2017/746).
Topics
- ISO 13485 – History, purpose,
scope and future
- Quality management system
– The big picture, CE-marking
- Relation with
ISO 9001 / LVFS / MDD / MDR
- Requirements and interpretation of EN ISO 13485:2016
- Quality management systems
- Management responsibility
- Resource management
- Product realization
- Measurement, analysis and improvement
Target group
This course is intended for personnel within QA, development, production and management, as well as for internal auditors, process owners, and regulatory staff at companies within the medical device supply chain.
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