Bespoke Training

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TRaC can support medical device manufacturers with training and mentoring, to help you gain compliance with the Medical Device Directive (MDD).

We understand the complexity of medical device product verification and validation and can help enhance manufacturers’ knowledge by providing specialist training and mentoring in order that you can successfully submit documentation to the Medical Device Directive (MDD) and distribute products into the global marketplace.

We can provide you with the following training services:

  • Risk Management – ISO 14971
  • Quality Management – ISO 13485
  • Software Life-cycle processes – IEC 62304
  • Usability Engineering File - IEC 62366 

We can also develop bespoke training sessions for clients who want to improve their understanding and how the clauses are interpreted.

We can help you reduce the risk and cost of getting your product to market on time and give you confidence when submitting documentation to your Notified Body.

To learn more about how our bespoke training for medical manufacturers can add value to your business, email your requirements to contact.us@element.com, enter your details into the blue form or call us on the number in the top right corner of this page.