- Medical Device Development : US, EU, UK
The medical device regulatory path is predicted by a defined set regulations and guidances in the US, UK and EU and illuminated by effective communications with FDA. 
  • BRC's teams integrate regulatory, clinical and engineering expertise to clarify and fill gaps in the choice of the predicate device, bench and (if needed) performance or clinical testing, biocompatibility testing and submission reports essential to meet agency requirements in the US, EU and UK. 
  • BRC offers e-submission services for 510(k) and PMAs and partners . 
  • BRC offers an international presence for clients focusing on strategic regulatory path finding; expert regulatory services and technical testing; cost containment; and expert preparation and submission of your device applications.
                                 Your medical device application must be scientifically-grounded 
                                 and conform with regulatory requirements for submissions to
                                 assure a successful and timely agency review.
                                 Early engagement of BRC with your device development program
                                 speeds the process and in our experience reduces overall costs.
                                                                                                   Contact us for an estimate.
 Recent Client Feedback on BRC
  • Hi Bill! Thank you!!! Awesome news! The whole company is very happy about our device clearance, 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 briefly discuss the next steps that we can take together?
    Head or R&D, International Medical Device Company.

Regulatory Services
for Devices

Creating the Predictable Path
BRC delivers a concise three step process that makes the critical match of the right regulatory path to the right battery of technical validation, safety and bench, performance and/or clinical testing.

Quality Systems Management

Complying with QSM Regs
BRC provides expert assist-ance for device companies setting up their quality plan and SOPs to comply with quality system management regulations.

FDA Inspections
​BRC also assists device companies in responding completely and in a timely fashion to FDA observations from company inspections.
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Postmarketing
​Services 

Complying with Postmarket Reporting​
Medical device companies are responsible for active moni-toring their their product's performance after agency clearance or approval.
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BRC provides complete serv-ices for reporting performance and safety reports to regula-tory agencies.