White Paper

Understanding safety and performance requirements for medical device submissions

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By Engaged Expert

James Pink

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James is the Senior Director of global medical technology testing, inspection, and certification for Element RegNav. He is an accomplished technical expert with a 25-year career in medical technology product safety and market access. He has audited hundreds of medical device companies as part of the European CE marking requirements.

Download this whitepaper by James Pink from Element RegNav, discussing the process to bring medical technologies to market, the regulatory pathways for the FDA (e.g., 510(k)), and 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 that your product has 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. 

Therefore, taking time to evaluate regulatory pathways early in the development of a product will mean that you better understand evidence requirements and minimise the likelihood of material issues arising during regulatory approval processes.

Why download this white paper? 

This free white paper covers the following topics:

  • FDA regulatory pathways for medical devices
  • Device classification and characterisation
  • Generation of evidence against essential principles

For more information about our regulatory intelligence services for medical devices, contact the Element RegNav team today. 


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Element RegNav

The future of medical device compliance: intelligent, automated, reliable.

RegNav is a regulatory intelligence platform that generates a complete view of your non-clinical safety and performance requirements from a comprehensive range of data sources (regulations, standards, guidance documents etc.).  We can create a comprehensive list of standards and requirements for your device in less than 2 weeks or, if you have an existing compliance plan, we can verify it for free.

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