Independent, experienced, results driven Consultancy serving medical devices, biotechnology and life science sectors. Project management expertise in design and development of medical devices, implementing best fit business / product strategies and management systems. Developing efficient, validated processes and controls, to meet national and/or global standards. Submitting applications & liaising with national authorities to gain regulatory clearance in your chosen territory.
Via consultancy, training, in-house expertise, advice provision and remediation, we support investors, clinicians, inventors, researchers, designers / specification developers, manufacturers, CRO’s, suppliers, importers, contract manufacturers and licensors.
Supporting clients in the UK, EU, US, Canada, Switzerland, Norway, China, Taiwan, Australia, Japan, Brazil, Israel, and Mexico, to successfully implement and maintain some + 100 QMS and obtain market clearance / re-certification of + 4,000 devices to date.
- Provide innovative, responsive, consulting, training and support services that deliver value to each Client’s organisation and enterprise
Engage and partner with experienced, professional associates and organisations to deliver a broad range of practical, efficient, quality improvement and compliance solutions
Develop and apply our expertise with diligence, consideration, enthusiasm, openness and integrity
Deliver what we promise to ensure Client satisfaction
Maintain ethical standards of professional conduct
Remain profitable to invest and grow