The harmonised EN ISO 13485:2016 standard is used for 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 the applicable sections of the Medical Device Directive (MDD 93/42/EEC) or Medical Device Regulation (MDR 2017/745).
This course explains the requirements of the standard and describe its interpretation and application. The course provides a basic understanding of the requirements and how to design, deploy and maintain a working quality management system. Having a quality management system according to ISO 13485:2016 is, in many cases, a prerequisite to getting a CE-mark.
- 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
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.
After the course, participants will have a basic understanding of the new ISO standard and how to establish and maintain a quality management system based on it.
Recommended prior knowledge
A basic knowledge of quality systems, such as ISO 9001, 13485, GMP, etc. is recommended.
Course material will be in English, verbal presentation and discussions in Swedish or in English, depending on the participants.
Nils-Åke Lindberg, CEO and Principal Consultant
Camilla Drott, Quality and Regulatory Consultant
Dates and location
To be planned
20 – 21 October
To be planned
2-day course: SEK 11 900:-
All prices excl. local VAT.
*For group registrations, the 2nd and 3rd persons from the same company will receive a 10% discount. For 4th and additional persons, a 20% discount will be applied.
Customized training courses and seminars
We provide training courses and seminars, both as open courses / seminars and
as customer specific trainings.
The course is organised in collaboration with Intertek.
Do you want to know more about this course? You are welcome to contact us at firstname.lastname@example.org for more information.