Thu, Feb 13 | Webex

CE Marking & FDA Regulations Workshop

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

Time & Location

Feb 13, 2020, 2:00 PM GMT
Webex

About the Event

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

FDA

  • 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

Outcomes

  • 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

Registration is Closed

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