• Psephos

MDR/IVDR Technical File / Risk Management / QMS Workshop - 21 May 2020

SEHTA and Psephos Biomedica are running their next workshop on MDR/IVDR Technical File/Risk Management/QMS on 21 May 2020


This one-day event will provide you with an overview and insight into:


  • Quality Management Systems 

  • Medical Device Technical Files

  • Risk Management

  • Assist you in assessing your company’s current preparedness

  • Provide a practical guide to the next steps that you and your company need to take to meet Technical documentation and Quality Management System requirements to gain CE Marking under the MDR/IVDR


Outcomes:

  • Gain an overview of the EU MDR/IVDR 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


Register now


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