Compliance to FDA, EU & Health Canada
Requirements

Start-up quality system implementation

US FDA - 21 CFR, Part 820 - Quality System Regulation

ISO 13485 Implementation

ISO 9001 Implementation

ISO 14971 -  Risk Management throughout product life cycle

BS EN 1789 - Road Ambulance Testing

IEC 60601-1 3rd Edition Compliance

Health Canada Quality System Compliance

Gap analysis evaluation of existing systems

Technical writing of policies and procedures

Designing, revamping and instituting quality systems processes
BQC CONSULTING
    Beyond Quality & Compliance
Compliance
Our services are
founded on the
following tenets:  
due diligence,
integrity, and a
passion for
excellence
.
Value added creative solutions for your business