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).
Are you:
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.
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:
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.
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.
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.
For more information and to apply, please fill in the contact form:
Please note the following:
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
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