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;

  • Establish & agree defined project objectives, detailing tasks and allocation of resources to meet documented timescales, including as appropriate liaison with  / applications to Notified / Approved bodies;

  • Devise, engage, agree and implement appropriate compliant solutions that address and meet specified those agreed objectives & plans:

  • Diligently monitor, manage and communicate project progress and status of compliance;

  • Drive, engage and implement necessary actions to enable objectives and timescale fulfilment;

  • Liaise with your EU Responsible Person to enable EU & EUDAMED Registration;

  • Complete EUDAMED, UKCA & UKNI Registrations.

QA and RA Consultancy Examples

Our support services are diverse and international and range from:

  • Defining device intended use / purpose, design & development diligence;

  • Defining regulatory strategy to enable device clearance(s) to market(s), launch and revenue generation;

  • Implement systems of control to meet regulation and standards to gain Quality Management certification;

  • Addressing Human Factors, usability specifications and human / interface control embracing software;

  • Preparing & implementing Risk Management Plans

  • Establishing compliant design, development and change control processes to meet regulation & standards;

  • Specifying, evaluating, testing materials, components or device to meet both functional, mechanical, electrical and biocompatibility requirements;

  • Providing QA / RA support for Clinical Investigation Application, Plan, Protocol Development;

  • Evaluating suppliers and/or contractors, validating contracted processes, specifying & agreeing Technical  / Quality Agreements, securing traceability & supply integrity;

  • Developing, implementing plans for FDA, CE, UKCA, UKNI, UDI & EUDAMED Registrations & EN ISO 13485:2021 certification;

  • Defining & validating processes including environment controls, molding, packaging, labelling, sterilisation, stability, shelf-life, storage & transport.

  • Preparing, collating, submitting Technical Documentation (DHF & DMR) to meet Regulatory Requirements;

  • Preparing and implementing PMS, PMCF and Reporting Plans

  • Conducting investigation(s), Audit(s), Analyses, Problem Solving and Correction services to address specific device, material, QMS, process or PMS incidents for Economic Operators;

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 Marking, FDA PMA, 510k and licensing / registration for clearance in Australia, Brazil, Canada, China, Israel, Japan, Mexico, Saudi Arabia, Switzerland, Taiwan and UAE.

Get In Touch