"We provide knowledge and information about CGMP and Quality Systems to the Life Science industry"

Compliance Seminars®

Medical Device equipment

Effective Management Controls
– for Medical Device Firms

Course description:

This course provides you with the knowledge and confidence to interpret the ISO 13485:2016 and US Food & Drug Administration’s Management Responsibility requirements in the Quality System Regulation for your company’s operations.

In one fast-paced day, you will learn the key requirements of executive leadership for establishing and monitoring the Quality Management System in a risk-based paradigm for medical device or combination product companies.

Course outline:

  • Management Responsibility, including Management Review and personnel
  • A subsystem model for evaluating Quality Management System effectiveness
  • Key quality indicators in the QMS
  • Corrective and Preventive Action from an executive perspective
  • Internal quality audit from an executive perspective
  • Using risk in the QMS infrastructure
  • Risk-based decisions – where they are appropriate
  • Examples of implementing a risk-based management model

Note: This course is presented electronically. Each attendee must bring their own laptop to the course venue, Adobe PDF Reader is essential to fully participate in the course.

Course objectives:

  • Review and discuss the Management Responsibility requirements.
  • Highlight key data in the Quality Management System that support Management Review and executive decision-making.
  • Discuss Corrective and Preventive Action and internal quality audit as key executive management support tools.
  • Discuss context of risk-based decision making and review opportunities to adopt a risk-based approach throughout the QMS.

Who should attend:

Intended for executive management of medical device or combination product companies, this fast-paced course is ideally suited to staff with responsibility for evaluating effectiveness of a Quality Management System. It is also intended for Management Representatives, and key staff responsible for Internal Audit.



When attending a Key2Compliance® course, you get access to Gate2GMP®, our document library and search tool.
At Gate2GMP® each course has its own page where you can download course materials, receive up to date information and communicate in the course forum.
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.

Make an enquiry




Course facts

Course no:
Medical Device industry

US and EU


Date, location and venue:

No planned open course.

This course is offered in-house.
Click here for more info and inquiry form.

1 day
08.30-16.30 (Registration 08.00-08.30)

Price (excl. local VAT):
6 400 DKK (€ 850) incl. course material (pdf), lunch 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 we offer the following quantity discount:
2-3 persons 10%
4 or more 20%
We do not offer or practice any general company discounts without commitments and/or written agreements.

Course material (Handouts)  
No printed course material will be provided on our courses*.
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.
1-2 weeks prior the course you will receive login details to www.Gate2GMP.com where you can download the course handouts as a PDF.
Note pads and pens will always be provided at the venue.

Cancellation policy - Compliance Seminars®  

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.