SGS MDR certification services provide a one-stop solution for your medical devices.

Are you working to achieve MDR conformance?

Are you:

Working in medical device manufacturing or related specialist services, product development or quality/regulatory?
A science or engineering graduate?
Considering a career in or already in auditing?
Based in an EU based manufacturing enterprise or those with an Authorised Representative in the EU.
An SME looking to upskill staff in MDR?

If the answer is “yes”, then apply for our fully EU-funded, online postgraduate-level modules. EU funding means we can offer a place – usually costing EUR 1,500 – without charge. (Available up to February 2026)

Medical Devices (MDR/IVDR)

Postgraduate Certificate

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The rapidly growing and innovative medical device sector is crying out for highly skilled auditors, product assessors and clinical reviewers, among other experts. It especially needs people competent to implement the EU Medical Device Regulation (MDR).

Understanding MDR with respect to the creation and assessment of the full Technical Documentation and the Clinical Evaluation Report is crucial for Medical Device manufacturers.

These courses will support enterprises on the journey to MDR compliance. Graduating may also be the first step to a potential career as an Notified Body auditor and/or product assessor.

Disclaimer: Co-funded by the European Union. Views and opinions expressed are, however, those of the author(s) only and do not necessarily reflect those of the European Union or the European Health and Digital Executive Agency (HADEA). Neither the European Union nor the granting authority can be held responsible for them.

101101269 – NoBoCap – EU4H-2022-PJ

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SGS Ireland Limited

+353 1 295 0654

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Hazel House, Millennium Park, W91 PXP3, Naas, County Kildare, Ireland

Important Information

Please note the following:

All modules will be available in 2024 and 2025. Registration will be open approximately two months before starting date.
Priority will also be given to SMEs and to ensure a good geographical coverage between EU countries.
It may be necessary to limit applicants to one per enterprise.
On receipt of an inquiry, a registration form will be sent which must be completed in full and returned as soon as possible.
Confirmation of a place will be sent ten working days before each start date.
*It is not a requirement to have completed Module 1 but priority for Module 2 and 3 will be given to those who have completed Module 1 or work in the medical device or IVD sector.

NoBoCap

The NoBoCap project is a groundbreaking initiative within the EU4Health Programme committed to fostering a conducive environment for swift and efficient advancement in the Medical Technology (MedTech) sector.

Our mission is to bridge the gap between Notified Bodies (NBs), the Medical Device Industry (MDI), Market Operators (MOs), and other players streamlining the complex process of dossier submissions, reviews, and approvals.

This module teaches the skills and knowledge to adeptly audit against MDR, whether you want to become an internal or full-time auditor, or a product assessor.

Start date May 6^th 2024 (Applications now closed)
10 weeks (8 in the virtual classroom, 2 for online assessments)
100% online
Postgraduate CPD certificate worth 5 credits
Accredited by Technological University Dublin (TU Dublin)
Led by Dr Geofrey De Visscher, Head of SGS’s European MDR Notified Body (NB)
The final award is a CPD certificate in Implementing Regulatory Requirements for Medical Devices, awarded at NFQ IRL Level 9 and EQF Level 7 without classification, accredited by TU Dublin.

Implementing Regulatory Requirements for Medical Devices

This module is a deep dive into the construction of the Technical Documentation and the Clinical Evaluation Report and builds on the learning from Module 1*.

Starting on March 4^th 2024 (Applications now closed)
10 weeks (8 in the virtual classroom, 2 for online assessments)
100% online
Postgraduate CPD certificate worth 5 credits
Accredited by Technological University Dublin (TU Dublin)
Led by Dr Geofrey De Visscher, Head of SGS’s European MDR Notified Body (NB)
The final award is a CPD certificate in Generating data for Technical Documentation (MDR), awarded at NFQ IRL Level 9 and EQF Level 7 without classification, accredited by TU Dublin.

Generating Data for Technical Documentation (MDR)

Generating Data for Technical Documentation (IVDR)

This module is a deep dive into the construction of the Technical Documentation and the Performance Evaluation Report and builds on the learning from Module 1*.

Starting on October 7^th 2024 (Applications open from June 24^th2024)
The closing date to apply August 30^th.
10 weeks (8 in the virtual classroom, 2 for online assessments)
100% online
Postgraduate CPD certificate worth 5 credits
Accredited by Technological University Dublin (TU Dublin)
Led by Dr Geofrey De Visscher, Head of SGS’s European MDR Notified Body (NB)
The final award is a CPD certificate in Generating data for Technical Documentation (IVDR), awarded at NFQ IRL Level 9 and EQF Level 7 without classification, accredited by TU Dublin.