What are you looking for?

Open for Registration: SGS-led MDR Masters-Level Module to Support MDR Implementation and Increase MDR Auditing Capacity

July 26, 2023

It is time to support the medical device sector’s demand for skilled auditors, product assessors and clinical reviewers. Find out more.

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).

Apply for our EU-funded, online MDR Postgraduate Course

Are you:

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

If the answer is “yes”, then apply for our EU-funded, online Implementing Regulatory Requirements for Medical Devices postgraduate-level module. EU funding means we can offer a place – usually costing EUR 1,500 – without charge.

NoBoCap and Co-Funded by the EU-POS

What does the module cover?

Starting on September 25, the 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.

Key features:

  • 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)

What do you gain from certification?

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.

For organizations, this module will support enterprises on the journey to MDR compliance. Graduating may also be the first step to a potential career as an NB auditor.

More modules coming soon

This is the first module in a series that is part of the EU4HEALTH NoBoCap Project. Further modules will include Generating Data for Technical Files.

About MDR and SGS designation

In May 2021, MDR officially replaced the Medical Device Directive (MDD) to enhance European patient safety through a more robust and transparent framework. This also brings medical device regulations in line with technical advances and progress in medical science and law-making.

Every MDD-certified medical device must certify to the new requirements to continue to be sold in the European market. All medical device manufacturers must register with an NB before May 2024 to ensure that their product(s) are audited against MDR before the deadline.

Our Belgian NB 1639 was designated a European MDR NB by the European Commission and Belgian Competent Authority (FAMHP) under MDR (EU) 2017/745 in December 2021.

With existing approval under the UK Conformity Assessed (UKCA) scheme, we are one of the few companies that can provide medical device certification services across the whole of Europe.

Are you suitable?

For more information and to apply, please fill in the contact form

Important Information

Please note the following:

  • Places will be allocated giving priority to those who previously applied and were unsuccessful as the cohort was full. 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, but there will be another cohort starting in 2024
  • On receipt of an inquiry, a registration form will be sent which must be completed in full and returned as soon as possible
  • The closing date for receipt of enquiries has been extended to September 1, 2023
  • The closing date for receipt of completed registration forms is September 8, 2023
  • Confirmation of a place for the September 25 start date will be sent to applicants by September 12, 2023

Disclaimer: 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

About SGS

We are SGS – the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 98,000 employees operate a network of 2,650 offices and laboratories, working together to enable a better, safer and more interconnected world.

News & Insights

  • SGS Ireland Limited

Hazel House, Millennium Park,

Naas, County Kildare, W91 PXP3,