Independent, experienced, results driven company serving medical devices, biotechnology and life science sectors since 1994. Project management expertise in device design & development, implementing best fit business  / product & operational strategies to meet national regulations. Developing efficient, validated processes and controls, (including supply and distribution chains), to meet regional, national and/or global ISO standards. Preparing/submitting applications & liaising with national authorities, gaining regulatory clearance and registration in your chosen territory on time.

Supporting investors, clinicians, inventors, researchers, designers / specification developers, manufacturers, CRO’s, suppliers, importers, distributors via consultancy, training, in-house expertise, advice provision and remediation.

Engaging with 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 + 4,500 devices to date.

UK Responsible Person for non-UK Manufacturers to register devices with MHRA.