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
5 – 6 October
Day 1: 09.30-16.30
Day 2: 09.00-16.00
The online course is held in cooperation with Intertek. More information for registration go here
SEK 11 900:-
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.
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.
We are longtime trusted providers of MedTech quality and system management, risk management, compliance, training, interim management and regulatory affairs. Offering a thorough knowledge and understanding of the industry, based on 30 years of professional experience, QAdvis have the tools to help take your MedTech innovations to domestic and international markets.