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.
REGULATORY:
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
RoHS II/REACh/WEE
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
REGULATORY:
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
RoHS II/REACh/WEE
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 (info@bnrmedical.com) to get BNR's proven expertise applied to your specific situation
