BNR medical device approvals 
ACCELERATING the compliance process

ACCELERATING the compliance process

BNR Medical Device Approvals will manage, simplify and accelerate the FDA process and the regulatory compliance part of your product launch objectives. 


Early collaboration with FDA
510(k) and PMA services
Risk Management
Formatting of FDA documentation
Design Reviews
EMC/Wireless & Product Safety:  Standards/Scope Identification (Gap Analysis)
Proper device description
Substantial equivalent review and discussion
Labeling requirements
Software presentation
Bench Tests
TCF (Technical Construction File) Review
TCF Generation and Maintenance assistance  
Conflict Minerals

Regulatory Compliance:
EMI/EMC "Design for Compliance Reviews
EMC vendor selection/interaction & project management
EMC Consulting for FCC/Canada
EMC Consulting for inclusion of wireless modules
Electrical Safety Consulting, Design Reviews, Preliminary Evals 

International Approvals:

Medical Device Directive for Europe
European R&TTE Directive (for wireless modules)
EMC/Wireless for Australia, Japan, Taiwan, China, Korea & India and more...
Medical Device Reporting (MDR)
Quality System  (QS) Registration


Call 408-674-9184 or email ( to get BNR's proven expertise applied to your specific situation

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