With you we provide practical, efficient, focused and expert Consultancy support, delivered by a dedicated, experienced team to guide you in specific aspects in, or throughout, your medical devices life-cycle.
We share with you extensive Quality Assurance (QA) Management Systems and Regulatory Affairs (RA) expertise to design, develop, implement, maintain and monitor controls systems to meet specific country medical device regulations and standards. With you we prepare, collate and submit the evidences necessary to gain and maintain market clearance such as CE Marking, Device Licensing and / or Registration as appropriate.
Your success is our aim whatever the scope or scale of the consultancy support required. Our value added services is founded on a commitment to clarify objectives and deliver defined, dedicated support to:
- Ensure a complete understanding of your requirement(s) by reviewing and analysing your business needs, supply chain, market and device development requirements and plans to establish and agree defined objectives;
Design and develop plans, detailing tasks and allocation of resources to meet documented timescales, including who does what by when
Devise, engage, agree and implement appropriate compliant solutions that address and meet your specified and agreed objectives
Diligently monitor, manage and communicate project progress and status of compliance
Drive, engage and implement necessary actions to enable objectives and timescale fulfilment
QA and RA Consultancy Examples
Our support services are diverse and international and range from:
Independent assessment of device development diligence and/or assessment of the regulatory strategy to revenue generation for Investors, Grant or Funding Agencies
Providing assistance in developing routes for regulatory clearance for commercialisation of IP / Technology clinical applications for Clinicians / Inventors / Research establishments / Designers and Specification Developers
Hands on support to define and implement systems of control to meet regulation and standards and gain Notified Body Quality Management certification to meet contractual commitments, and/or regulatory clearance / device CE Marking for Suppliers, Contractors, Manufacturers or Distributors.
Providing QA / RA support for Clinical Investigation Application, Plan, Protocol Development, Investigator Brochure, Investigation, Clinical Evaluation and Reporting for Manufacturers and Clinical Research Organisation’s (CRO’s)
Establishing compliant design, development and change control processes, usability specifications and human / interface control embracing software, to enable provision of safe devices that perform as claimed and intended by the Manufacturer
Specifying, evaluating and testing materials or components to meet both functional, mechanical, electrical and biocompatibility requirements for manufacturers
Evaluating and establishing suppliers and/or contractors, validating contracted process, specifying and agreeing Technical or Quality Agreements to secure traceability and control of batch records secure supply integrity for manufacturers
Preparing Risk Management plans, conducting hazard analyses
Developing, implementing plans (including Notified Body changes), to effect transition from the current EC Directives to EC Regulations for medical devices and in vitro diagnostic devices including EN ISO 13485:2016 certification, UDI and Eudamed registration
Process definition and validation for cleanrooms, molding, manufacture, packaging, labelling, stability, shelf-life, storage & transport for Manufacturers
Preparing, collating, submitting Technical Documentation and Technical Crises Response, Reporting, Investigation, Audit, Analyses, Problem Solving and Correction services to address specific medical device, material, QMS, process or post market surveillance incidents for Suppliers, Contractors Manufacturers and Distributors
QA and RA Consultancy Successes
To date we have delivered consultancy support services to medical device clients based in Australia, Canada, China, EC, 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.