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).

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Whatever stage you’re at, RegNav can support

We support medical devices across all risk classifications

All pathways for US and EU regulatory clearance and approval are covered

We support CE marking across a range of device types

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A full compliance plan, product classification and timeline.

  • Whether you are pre or post design lock, we can identify the standards that are applicable to your device.

  • You will receive a full outline of the regulations and standards that are likely to be required for your product.

  • Our AI assists with determining the most efficient testing pathway for you.

  • Your case will be fully overseen by leading compliance experts

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Expert validation of an existing compliance plan.

  • Use the tool for a free assessment of your compliance plan to assist with determining if you have found all applicable standards.

  • Making a design change? We can tell you how that will change your compliance plan.

  • Your case will be fully overseen by leading compliance experts