CE Marking & FDA Regulations Workshop

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