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Compliance Seminars®

QA/RA Leader Medical Devices

- Unique training to become QA-RA Leader / Person responsible for regulatory compliance

This 3-day tailor-made training is led by experienced trainers and combines theory with reality-based processes. The aim of the training is to make you well equipped and prepared to lead the QA/RA function in a medical device organization, to give you the latest information in the field of medical device regulations and quality system standards and provide a great opportunity to network with other quality managers.

When combined with in-depth training in Quality Management system and Medical Device regulations, such as our advance level training course “Medical Quality Management Systems” (#5314) you are well prepared for the position as QA-RA Leader, and the role as person responsible for regulatory compliance.
Read more about our complete training programs here »

The training also serves as preparation for personal certification as QA-RA Leader; Medical Devices. Read more about the certification process at at www.sbq.nu

Course description:

The person responsible for quality assurance and regulatory compliance in a medical device company need both broad and specific knowledge which must be documented. Further, the new EU regulations for medical devices (MDR) and In Vitro Diagnostics (IVDR) requires the manufacturer to appoint a person responsible for regulatory compliance who has specific responsibilities and must show documented evidence of expert knowledge in relevant fields. This training will provide you with valuable tools and knowledge needed for that role.

After completion of this course you will be prepared to….

  • Understand how medical device regulations are designed and expected to be observed.
  • Ensure products are in accordance with regulatory requirements before being introduced to the market.
  • Maintain product safety when the product is put on the market, by working with an implemented management system, including risk management and market surveillance, which meet the requirements of the regulations.
  • Have knowledge and understanding of how accident and incident reporting is supposed to work.

Who should attend:

The training is suitable for quality and regulatory professionals who want to strengthen their competency in medical device regulation and quality management systems, and need documented competency as “person responsible for regulatory compliance”. 

It is also designed to serve as preparation for a personal certification as “QA/RA Leader Medical Devices” (read more about the certification at www.sbq.nu.)

Take this training if you:

  • are experienced in the role as a Quality/Regulatory Manager or Quality Leader and wants to develop yourself further and get your skills documented.
  • need professional development that will benefit both you as individual and the organization.

Course outline:

  • Medical Device Regulations - Regulatory framework in EU and US, and (briefly) in other markets. The definition of a medical device. Requirements for market access in EU and US. General quality system requirements.
  • Role and responsibility of the person responsible for regulatory requirements as defined in MDR/IVDR .
  • Quality Management Systems - ISO 13485:2016, interpretation of the standard, how to assess and monitor the efficiency of the quality system. Release/control of a product under a QMS.
  • Product Development - The product development process – how to define the start and end of the development phase; demonstrate compliance to the regulations and decide on market release. The role of QA and RA in the development process.
  • Product maintenance – how to manage the content of the Design and Development files (DHF) in relation to changes to the product, in the production process and feedback gained from the market (PMS).
  • Marketing control - Post-market surveillance (PMS), Medical Device Reporting / Vigilance, Postmarket Clinical Follow-up, Control of Marketing materials.

Prerequisites (previous knowledge):

Two years’ experience or more of working with quality and regulatory questions in medical device or pharmaceutical industry. Training/knowledge about QSR and ISO 13485 corresponding to the content of our course "ISO 13485 and QSR (#5314)"



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Do you wish to customize this course to suit your needs?

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Course facts

Course no:
Medical Device

Intermediate / Expert
Mainly EU.
US and other areas will also be addressed.

No of participants:
Max 20

Tomas Camnell   Åse Ek
Tomas Camnell, Symbioteq Kvalitet AB
Åse Ek, Symbioteq Kvalitet AB

Date, location and venue:

8-10 December, Copenhagen, Denmark
Industriens hus
H.C. Andersens Blvd. 18    

Register by 4 November - Save 2 250 DKK (€ 300)

Specify our booking code D000030870 to get a discount when making a reservation at a Scandic Hotel.
Scandic Hotels nearby:
» Scandic Webers (500m)
» Scandic Kødbyen (800m)
» Scandic Copenhagen (800m)

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


3 days:
Day 1: 10.00-appr. 19.30*   (Registration 9.30-10.00)
Day 2: 8.00-17.00
Day 3: 8.00-16.00
*Note. Evening session as group workshop. The time can vary.
Evening meal is not included.

Price (excl. local VAT):
Register by 27 Oct - Save 2 250 DKK (€ 300)
Until 27 Oct: 16 760 DKK (€ 2 250)
From 28 Oct: 18 990 DKK (€ 2 550)
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.

Certification test online
The individual certification test is carried out separately by SBQ Certification AB.
» More information and application at www.sbq.nu

For groups registered and invoiced together for the same course we offer the following quantity discount:
3 persons or more 15%
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.
3-5 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 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 14 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.