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).
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 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.
Nils-Åke Lindberg, CEO and Principal Consultant
Camilla Drott, Quality and Regulatory Consultant
Dates and location
To be decided / On request
To be decided / On request
Day 1: 09.30-16.30
Day 2: 09.00-16.00
Online SEK 12200:-
Onsite SEK 12800:-
All prices excl. local VAT.
Group registration for QAdvis managed courses*
*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.
Cancellations must always be communicated to Academy@qadvis.com and confirmed by us. Cancellations made more than 4 weeks before the starting date are free of charge. Cancellations made 4–2 weeks before the starting date of the event will be refunded by 50%. Cancellations made less than 2 weeks before the starting date of an event will not be refunded. If you are unable to attend, substitution with a colleague is possible and recommended.
QAdvis reserves the right to cancel the course due to low attendance, up until 2 weeks before the course start. You can contact us at any time to get a status update. If the course is cancelled, a full course fee refund will be offered, but no additional reimbursements. We reserve the right to change the agenda, time and location, up until 2 weeks before the course.
QAdvis reserves the right to change teachers or reschedule the course due to force majeure or due to teacher’s illness. No compensation will be paid for any additional costs incurred.