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CE Marking & FDA Regulations Workshop - Thursday 13th February 2020

SEHTA and Psephos Biomedica are running their next workshop on CE Marking & FDA Regulations requirements.

Medical technology developers are faced with choices on which markets to access first. The EU and the US represent 2/3 of all spend on medical devices and so understanding what is required to access these two markets is essential.

This one day interactive workshop will provide an overview of:

CE Marking

  • MDR CE Marking Process and the role of a Notified Body and Competent

  • AuthorityMDR Device Classification

  • MDR Conformity Assessment routes for class I, IIa, IIb and III products

  • Compiling Technical Files, Clinical Evaluation Reports & the Declaration of Conformity

  • Clinical Investigations


  • How the FDA is set up and how medical devices are regulated in the USA

  • The different routes to market access for example 510k , PMA and Denovo

  • Substantial Equivalence

  • Quality Standards Regulations/ General Controls/Special Controls

  • Investigational Device Exemptions (IDEs)

  • Practical requirements to export medical devices to the USA & Useful information


  • Gain an overview of the EU MDR Medical Device CE marking Process

  • Gain an overview of the FDA requirements

  • Understand the key areas of compliance required

  • Understand the technical documentation that should be in place for each device

  • An opportunity to discuss next steps, action plans and areas requiring clarification

Register now

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