With founder Bernard Tremaine retiring as Managing Director of MDQAS, the company was acquired by Advena Ltd on July 1st 2015.
MDQAS remains unchanged as a UK registered company in location, telephone number and website. The high level of service provided by MDQAS will be continued via the Advena team who have signed legal confidentiality agreements with MDQAS.
We have compiled a list of frequently asked questions for your information below – if you have any further questions or queries, please just contact us >
Frequently Asked Questions
Why is Advena acquiring MDQAS?
Having provided MDQAS clients with an exemplary service for over twenty years, Bernard approached Advena to become the guardian of his consultancy company in order to ensure that MDQAS clients would continue to benefit from the same high level of service upon his retirement.
Advena and MDQAS have worked together for many years as active members of the European Association of Authorised Representatives, sharing the same ethos to lower the cost and complexity of compliance for our clients, with a friendly professional approach.
Who is Advena?
Advena specialise in lowering the cost and complexity of compliance for small and medium-sized manufacturers of medical devices and cosmetics. Established in 1996, we have completed a multiplicity of consulting projects across the world and employ highly experienced practitioners with over 30 years experience in regulatory and quality affairs.
Advena is certified by British Standards (BSI) for conformity to ISO 13485 for European Authorised Representative service, quality management, regulatory affairs and document creation and control for medical device manufacturers.
How will this affect my European Authorized Representative contract/mandate?
All MDQAS European Authorised Representative (AR) contracts (mandates) and fees remain unchanged as well as the MDQAS contact address legally required on product packaging and labelling or on any associated Notified Body EU certificate.
New invoices for the annual renewal of MDQAS contracts will be issued by the Advena Ltd accounts department and will clearly state that although the sums invoiced relate to existing client contracts with MDQAS they are to be paid to Advena Ltd.
Who should I contact?
Please contact John Adcock (firstname.lastname@example.org) or a member of his team (MDQAS@advenamedical.com). All existing MDQAS contact details will be forwarded to the Advena team.
What has happened to Bernard?
Bernard is now retiring from his full-time role running MDQAS. However, we are delighted that Bernard has now agreed to join the Advena team as a senior part-time consultant.