MEDDEV QA Ltd has the experience to help you grow!
MEDDEV QA Ltd is an independent, UK based consultancy and working mainly within the areas of Product Development, Regulatory Affairs and Quality Systems. MEDDEV QA specialises in the Medical Devices industry and offers a professional service specifically designed to assist companies of all sizes from start up companies to established multi-national companies.
MEDDEV QA can offer technical guidance on CE marking requirements and regulatory strategies leading to the commercialization of new products as well as the implementation of quality management systems meeting the requirements of 21 CFR 820, the Medical Devices Directive 93/42/EEC and ISO 13485 (including CMDCAS). MEDDEV QA can also provide training in these areas. MEDDEV QA has worked with companies ranging from start-up companies to multi-national market leaders.
MEDDEV QA can carry carries out internal audits, vendor audits and gap analysis quality and regulatory compliance audits for medical device manufacturers
MEDDEV QA can assist in the preparation of Technical Files and Design Dossiers to meet the requirements of Directive 93/42/EEC and assist in compliance issues related to sterilization and microbiological control of production.
Dr Simon Richards, the Managing Director of MEDDEV QA, has over twenty years experience in the medical devices industry and has developed an in-depth knowledge of medical devices and their regulatory requirements both the EU and globally.
Simon’s involvement with medical devices started out in 1990 in the Medical Devices Directorate within the UK Department of Health where he was responsible for ensuring the safety and quality of medical devices (with particular reference to sterilization and disinfection processes, packaging materials, wound care products and sterile single‑use products). Duties involved investigating adverse incidents, developing technical specifications, managing research projects, product approvals for the Drug Tariff and performing quality system audits as a Microbiologist and Team Leader under the Manufacturers Registration Scheme.
After three years with the Medical Devices Directorate Simon joined SGS UK Ltd to assist them in becoming a Notified Body under Directive 93/42/EEC. As Medical Devices Certification Manager he helped establish them as one of the leading medical device Notified Bodies whilst also undertaking quality systems audits of medical device manufactured globally as well as reviewing Technical Files and Design Dossiers.
n 2004 Simon left SGS to take up an RA/QA role with Biomet UK Ltd, a leading multi-national manufacture of orthopaedic devices, eventually becoming Director of QA/RA.
In 2010 Simon left Biomet UK to set up MEDDEV QA Ltd. With experience within Industry, a Notified Body and the UK Competent Authority Simon is ideally placed to provide an unrivalled support service to all sectors of the Medical Devices industry.
As a Microbiologist Simon is ideally placed to advise on compliance issues related to sterilization and microbiological control of production.
An ‘Authorised representative’ means any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive;
Under Article 14 of the Medical Devices Directive where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single Authorised Representative in the European Union. For Class I devices, the Authorised Representative shall inform the Competent Authority of the Member State in which he has his registered place of business of the address of the registered place of business and the description of the devices concerned.
MEDDEV QA, in its role as Authorised Representative, can assist in communicating with Competent Authorities regarding EC Vigilance reporting requirements and the recall of products.
If you need an Authorised Representative in the EU then MEDDEV QA Ltd can provide this service cost effectively. Contact us for further details.
MEDDEV QA Ltd
5 Hillside Drive
Vale of Glamorgan
You can trust that your business and personal matters will be handled with professionalism, integrity, and the utmost discretion. The end result will be accurate, on time, and get you great results.