"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"
Medical Device Quality Management Systems (QMS)
Key requirements in ISO 13485, MDR *, and QSReg **
*MDR - EU Medical Device Regulation **QSReg - US Medical Device Regulation 21 CFR 820
During this three day course you will get a good insight and understanding of the key requirements that shall be fulfilled to establish and maintain a quality management system in compliance with EU and US Medical Device regulations.
The course provides practical guidance on how to implement the requirements in your quality management system and how to deal with critical elements of the quality management system such as; design control (product development), manufacturing, validation, management responsibilities, handling of resources, internal audits, change control, post market surveillance and CAPA management.
During the course you will also get a thorough understanding of the major changes in the newly updated ISO 13485:2016, as compared to the 2003/2012 version and its relation to the new Medical Device regulations (MDR/IVDR).
Participants will learn how to effectively implement a quality management system in line with the requirements in QSReg, ISO 13485:2016, MDR and IVDR. Completion of this program will give you the knowledge needed to establish and implement a new quality management system or assess your current quality management system and implement improvements where needed.
For further professional development this course may be combined with any of our two advanced courses to become “Auditor/Lead Auditor Pharmaceuticals and Medical Devices” (#5316) or “QA-RA Leader Medical Devices” (#5317).
Read more about our complete training programs here »
These two courses both serve as relevant preparation for a personal certification. The certification is optional and separate from the course. More information about personal certification is available at www.sbq.nu/
- Purpose of a Quality System
- Process approach
- Management responsibility and human resources
- CAPA system
- Document controls; interrelations and traceability
- Risk management
- Product development
- Supplier control
- Material handling
- Production/process controls and infrastructure
- Measurement, analysis and improvement - PMS and Vigilance
- New EU Medical Device Regulations (MDR and IVDR)
- MDSAP and ISO 13485
Who should attend:
The course is suitable for persons working with R&D, production, process development or QA who is involved in, or responsible for the operation or audit of a Quality Management System (QMS) for medical devices.
Also those who need more knowledge about QSReg as well as the ISO 13485 standard and it’s relation to the new Medical Device regulations (MDR/IVDR) will benefit from this course.
Need of prior knowledge/experiences:
- You should have basic knowledge of quality systems, e.g. by participating in one of our basic courses or have equivalent knowledge of the company's internal quality assurance programs.
- You should have at least 6-12 months experience of working in the regulated industry (medical device or pharmaceutical industry).
If you are uncertain about your level of basic GMP knowledge, you can buy and take an online test here »
For this course you will receive a Certificate of completion. If you want to upgrade to a Certificate that also show verified knowledge, you now have the option to take an online test. The questions are related to the course content and after passing the test (min 70% score) you will get an additional Certificate with reference to both the course and that you have passed this test – an objective evidence that you have the expected knowledge. The test is included if concluded within 30 days after the course.
When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.
Watch this short video to learn more about what Gate2GMP® offers »
Bring this course in-house?
Are you a group in need of the same training?
Do you wish to customize this course to suit your needs?
If so, running the course in-house is probably the best and most cost effective solution.
"Thanks a lot for this efficient traning. It was really useful."
"Interesting topic and very good and knowledgeable course leaders."
"Good balance of theoretical course, breaks and practical works in groups"
Intermediate / Advanced
EU, US and
global (ISO 13485)
Date, location and venue:
Preliminary April/May 2020, Copenhagen, Denmark
This course is also offered in-house.
Click here for more info and inquiry form.
09.00-17.00 (Registration 8.30-09.00 day 1)
18 990 DKK (€ 2 550)
Incl. course material (pdf), lunches and refreshments
Note. Due to tax/VAT regulations within the EU (for courses/seminars/conferences), the course fee is invoiced in the local currency and local VAT is added.
Accommodation is NOT included in the course fee.
For groups registered and invoiced together for the same course we offer the following quantity discount:
2-3 persons 10%
4 or more 15%
We do not offer or practice any general company discounts without commitments and/or written agreements.
This is primarily to protect the environment. Therefore, we encourage you to bring a laptop / tablet to the course - it is possible to make notes in the PDF file you will have access to.
3-7 days prior the course you will receive a download link for the course handouts as a PDF.
Note pads and pens will always be provided at the venue.
Cancellation of registration:
Registration is binding and when you have received our confirmation the following conditions are known and accepted. If you for any reason is unable to attend, substitution is always possible and preferred.
All cancellations and/or substitutions must have been communicated with and confirmed by us.
Cancellations received less than 30 calendar days before course start are subjected to a service charge of 150 € (Euro)/registered course day as compensation for additional administrative burden and for non refundable part of the conference reservation. Cancellations received less than 7 calendar days prior the course, or failure to cancel or "no-show", will be charged in full.
Cancellation of courses: Courses may be cancelled by the organizer if bookings fail to reach minimum numbers (normally not later than 30 days prior the course start), or due to other reasons beyond our control. In such circumstances charged course fees will be refunded, credited, or granted to attend another course for the same value. NOTE! Key2Compliance AB is NOT responsible or liable to any costs in conjunction with a cancelled course. If you need to book flights way ahead (+35 days prior the course) check with us before finalizing the purchase of flights and/or hotel accommodation for an update on the registration situation.