What are you looking for?

SGS Launches MDR Masters-Level Module to Bolster Auditor Numbers

March 24, 2023

Time to support sector demand for skills

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 versed in EU Medical Device Regulation (MDR).

On the lookout for…

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. EU based (but not essential)?
  5. A company looking to upskill people in MDR?

Is the answer “yes”?

If “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 about EUR 1,500 – without charge.

NoBoCap and Co-Funded by the EU-POS

What does the module cover?

Starting on May 9, the module teaches the skills and knowledge to adeptly audit against MDR, whether you want to become an internal or full-time auditor. It also covers related standards, such as ISO 13485 (medical devices – quality management systems).

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.

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

More modules coming soon

This is the first module in a series that is part of a larger EU-supported 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 or contact:

Kevin Callaghan
Knowledge Business & Training Services Manager
SGS Ireland
t: +353 87 6688500

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

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