Medical Device Regulatory Consulting - US, EU and UK
  • The medical device regulatory path follows a typical algorithm defined by regulations and guidances. At times, a novel device or drug-device combination may pose options that are less well clarified. ​When the device or device combination has a more complex path, then clarification is needed through agency dialogue and external expert advice.  
  • BRC teams integrate clinical and engineering expertise with in-depth knowledge of medical device regulatory affairs and agency communications. 
  • All in all, BRC delivers: strategic focus for regulatory pathfinding; expert regulatory services and technical testing; cost containment; and expert preparation and submission of your device applications.
  • Early engagement of BRC medical device teams speeds the clarification of issues, creates efficiencies, and ensures your medical device application is scientifically grounded for a successful agency review.

Head of Research and Development on recent approval of 510(k) application:
"Hi Bill! Thank you!!! Awesome news! The whole company is very happy about this and the timing is also perfect since we are here at the trade fair....Can we arrange a meeting for the second half of next week to discuss the next steps that we can take together? [2019]

BRC Approach to Supporting US Med Device Development - click Contact Us for EU, UK support

The Right Path
The Right Plan

BRC delivers a three step process that makes the critical match of the right regulatory path to the right battery of technical validation, safety and clinical testing.

Medical Device Applications

BRC's regulatory management of PreSub meetings, third party reviews and FDA interactions supports its client-oriented "early to market" perspective.
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Postmarketing
​Services

​BRC provides a comprehensive approach to ensure the post-marketing experience with your device meets regulatory requirements of safety, usability, and lifecyle improvement.