All RSQA’s key personnel were formerly employees of the former Medical Devices Agency (now known as the Medicines and Healthcare products Regulatory Agency (MHRA)) - the UK Competent Authority under the Medical Devices Directive 93/42/EEC, and part of the UK Department of Health. Their various former roles within that Agency make them uniquely qualified to advise upon UK and European medical devices matters.
Pharmacist and Qualified Person. Will joined the Department of Health in 1983 to work on pharmaceutical and medical device supply and technology. He has been active in leading audit teams into medical devices manufacturers of all types - but specialising in sterile products - since 1984.
He became an IQA / IRCA-registered International Lead Assessor in 1989, and from 1992 was the Professional Services Manager of the UK DoH Manufacturer Registration Scheme (MRS). In this capacity he acted as the UK’s arbiter on the Certification and Registration of device manufacturers and developed close links with industry, Governments, and Regulatory and Certification Bodies worldwide. He is also CMDCAS-qualified.
He was responsible for the the Medical Devices Agency’s programme of training Notified Body auditing staff through secondment to MRS audits, and has lectured at international forums on regulatory and quality systems topics.
Microbiologist and Qualified Person. Steve joined the Department of Health in 1992 as an auditor for the Manufacturer Registration Scheme (MRS) following an earlier career in pharmaceuticals and medical devices Quality Assurance, and including twelve years with a well-known practice of consulting microbiologists.
He became an IRCA-registered Lead Assessor in 1995, and has led more than 40 audit teams into a wide range of medical devices companies. He is also CMDCAS-qualified.
With the ending of MRS’ assessment activities in 1996, Steve transferred to the European & Regulatory Affairs business group of the Medical Devices Agency where as the Agency’s Senior Auditor, he played a key role in the designation and surveillance of UK Notified Bodies. Whilst in post he provided regulatory advice on microbiological issues to a large number of companies, and was a key provider of guidance through publication and presentations to hospital CSSD staff concerning their obligations under Article 12 (Systems and Procedure Packs) of the Medical Devices Directive 93/42/EEC.
He joined RSQA in January 1999.
One time administrator with the MDA Manufacturer Registration Scheme responsible for the logistics in sending auditors to all parts of the world.
Philippe has a degree in modern languages from the University of Grenoble and is now responsible for logging and managing the varied work undertaken by the Consultants and Associates of RSQA Ltd and running the company’s main office.
RSQA Ltd also have contracted arrangements with a network of Associates, the majority of whom are IRCA Registered International Lead Auditors. All have many years experience of medical devices and contribute specific product knowledge and expertise in fields which include: