Medical Devices - Pitfalls and safeguards in robust evidence of safety and performance for regulatory submissions
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This whitepaper discusses the process of bringing medical technologies to market, the regulatory pathways for the FDA (e.g., 510(k)), how to work smarter to keep on top of the legislation surrounding conformity, and streamline evidence collection for assessment activities
Irrespective of the regulatory pathway that is applicable to your product, you will have to demonstrate you have valid scientific evidence of adequate safety, performance and efficacy throughout the lifecycle of the product. Failure to provide this information is a common reason for delays and rejection of regulatory documentation by FDA and EU Notified Bodies. This frequently leads to increasing costs and failure to obtain market access of a device that may have a positive health outcome and better safety profile.
This whitepaper helps lay out the clear path to compliance, and covers the following topics:
FDA regulatory pathways for medical devices
Device classification and characterisation
Generation of evidence against essential principles
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Author: Nicole Small
Nicole is our Senior Manager of the Medical Technology Team. She is an experienced regulatory professional with extensive experience in the testing and regulation of medical devices. Her career spans over 30 years, which includes leading on significant public safety issues, educational and operational programs for the MHRA (UK's regulator; Medicines and Healthcare products Regulatory Agency).
