Consultancy
Practical, efficient, focused and expert advices / support for researchers, designers, developers, manufacturers, importers and distributors, delivered by a dedicated, experienced team providing guidance in specific aspects in, or throughout the medical devices life-cycle and supply chain.
Sharing extensive Quality Assurance (QA), Quality Management Systems (QMS), Risk Management Systems (RMS) and Regulatory Affairs (RA) expertise to enable compliant, efficient processes for risk management, design & development, supply chain control, manufacturing / assembly, distribution, post market surveillance, monitoring & controls systems to meet specific country medical device regulations and standards. Preparing, collating and submitting the evidences necessary for national registration(s) and market clearance.
Our Methods
Our services are founded on a commitment to deliver defined, dedicated support on time and budget to:
QA and RA Consultancy Successes
Our support services extend to clients based in UK, Australia, Brazil, Canada, China, EU, Mexico, Russia, Switzerland and USA. GPB have successfully completed QMS Registrations, market clearance / re-certification of more than 4,000 Devices embracing CE, UKCA / UKNI Marking, FDA PMA, 510k and licensing / registration for clearance in Australia, Brazil, Canada, China, EU, Israel, Japan, Mexico, Saudi Arabia, Switzerland, Taiwan, UAE, UK.
