Having started my working life in 1984 as a mechanical engineering technician, specialising in Quality Assurance under BS 5750, my first medical device quality role was in 1991 with a company manufacturing electric suction devices for hospitals and clinics. It was an exciting time to be working in the medical device industry with the introduction of the Medical Devices Directive (93/42/EEC) in 1993 and the evolution of EN46001 into ISO 13485.

As my career progressed I worked with companies that manufactured operating theatre suction devices, asthma inhalers, syringes, infusion pumps, syringe drivers, medical lasers, orthobiologic devices, orthopaedic implants, breast implants, gastric bands and balloons, dermal fillers, IVD devices and reagents, and a variety of Software as a Stand-alone Medical Device products. Products from device Class I through to Class III.

My roles encompassed Quality Management, Regulatory Compliance and Post Market Surveillance for products marketed around the globe. I hosted Notified Body and Regulatory Authority audits and inspections and represented the interest of a major manufacturer in the global breast implant market during the PIP Breast Implant investigation and analysis by the European National Competent Authorities.

At the end of 2014 I decided to step away from the world of global corporate medical device manufacturing and set up my own business, offering consultancy services to medical device start-up companies. I had identified a need for these small enterprises to be able to tap into a flexible resource for quality and regulatory advice and activities from the early days of establishing themselves.

My first few projects involved the acquisition and transfer of CE mark for Class IIa devices, post FDA inspection QMS remediation and preparing a business for their ISO 13485 certification audits. I then took on couple of interim posts as contract Quality Manager and Regulatory Affairs Manager.