EU Medical Device Technical Files Workshop

12 June 2019
Hempsons, 100 Wood Street, London EC2V 7AN
Duration: 
10:30 - 16:00

SEHTA, Psephos Biomedica & Mosaic Surgical would like to invite you to attend our EU Medical Device Technical Files Workshop.

SEHTA Members: £240+ VAT per delegate

SEHTA non-members :£280+ VAT per delegate (it's free to join SEHTA - Please click here)

Why attend

The new EU Medical Device Regulation (MDR) is in its implementation phase and will be effective from May 2020. All medical devices will need to comply with this new legislation.  Similarly, the IVD Regulation (IVDR) will be in force from May 2022. Many companies are not yet ready for the journey let alone have a roadmap of how to get to compliance.

This one-day event will:

  • Provide you with an overview of the key requirements for technical documentation in order to comply with the MDR and your conformity assessment
  • Assist you in assessing your company’s current preparedness for the transition
  • Provide a clear, practical guide to the next steps that you and your company need to take to meet Technical documentation requirements to gain CE Marking under the MDR

Outcomes: 

  • Gain an overview of the EU MDR Technical Documentation Requirements
  • Understand the technical documentation that should be in place for each device
  • Understand the key areas of compliance required
  • Gain a plan of action for implementation and CE Marking under the new legislation

Target Companies: Medical Device companies and Pharma companies with combination products.

Target Market: C-suite, executives, product owners, medical officers, regulatory and clinical specialists within a company that need to understand the overall requirements of the new Medical Device Regulation for their medical devices to enable them to place a device on the market and to maintain access after May 2020. All company sizes will find it useful, but particularly helpful for smaller, resource constrained organisations.

Click here to book and to view the agenda.

Book now!

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