• Psephos

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


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

Recent Posts

See All

SEHTA & Psephos Biomedica - Series of MDR Webinars

In light of the ongoing situation with the Covid-19 outbreak which has forced the majority of us to work from home, SEHTA and Psephos Biomedica have launched a series of MDR webinars to enable you to

© 2020, Psephos Limited

All Rights Reserved

  • LinkedIn Social Icon

Tel: +44 1273 704 527