Consultancy
Practical, efficient, focused and expert Consultancy support for 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 device design & development, implement, maintain and monitor controls systems to meet specific country medical device regulations and standards. Preparing, collating and submitting the evidences necessary to gain and maintain market clearance such as CE, UKCA, UKNI, FDA, Device Licensing and / or Registration as appropriate.
Our Methods
Whatever the scope or scale of the consultancy support required, GPB’s value added services is founded on a commitment to deliver defined, dedicated support on time and budget to:
Ensure a complete understanding of your requirement(s);
Review & analyse business needs, supply & distribution chains, market and device development requirements & plans, including remediation(s);
Establish & agree defined project objectives, detailing tasks and allocation of resources to meet documented timescales, including as appropriate liaison with / applications to national authorities, EU Notified / UK Approved bodies;
Devise, engage, agree and implement appropriate efficient compliant solutions that address and meet specified, agreed objectives & plans:
Diligently monitor, audit, manage and communicate project progress and status of compliance;
Commit, engage, drive and implement necessary / efficient controls & actions to enable objectives, timescales and project fulfilment;
Be your UK Responsible Person for non-UK manufacturers and register devices with the MHRA
Liaise with your EU Responsible Person to enable EU & EUDAMED Registration;
Complete EUDAMED, UKCA & UKNI Registrations.
QA and RA Consultancy Successes
Our consultancy support services extend to clients based in UK, Australia, Brazil, Canada, China, EC, 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, Israel, Japan, Mexico, Saudi Arabia, Switzerland, Taiwan and UAE.