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.