Consultants to the
Medical Device Industry
Advena Ltd has been providing personalized, professional assistance to small to medium-sized medical device manufacturers, world-wide, since 1996.
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NEWS FLASH !!
EU Regulatory Changes affecting manufacturers; the need for a
“Qualified Person”
It is now almost certain that there will be a requirement written into the new regulations, based on the current guidance MEDDEV 2.7.10, that ALL authorised representatives and manufacturers, will need to demonstrate that they employ, or are contracted with, a “Qualified Person” with a person who has at least, quote;
- A diploma, certificate or other evidence of formal qualification awarded on completion of a university degree or of an equivalent course of study, in law, natural sciences, medicine, pharmacy, engineering or another relevant discipline, and at least two years of professional experience in regulatory affairs or in quality management systems relating to medical devices;
- At least five years of professional experience in regulatory affairs, or in quality management systems relating to medical devices.
Is your current Authorised Representative, who maybe a distributor, qualified?
Advena Ltd are suitably qualified for this role, but are you?
COSMETIC REGULATIONS EU 1223/2009
Do you manufacture Cosmetic products to be sold into the EU?
The new Regulation replaces the existing EU Cosmetics Directive (76/768/EEC) and introduces a number of changes that will affect both manufacturers and importers of Cosmetic Products within the EU. The new regulation will apply from 11th July 2013.
Talk to us about 'Responsible Person' contracts BEFORE the deadline!! Visit our new website www.cosmeticregulations.eu
Giving real answers
Whether your company is launching a medical device for the first time, or trying to expand into international markets, we are available to take the time to answer your questions and provide tangible feedback based on our real-world experience in communicating with medical device authorities.
Based at new state-of-the-art offices, with its own conference facilities, within Leamington Spa, Warwickshire, we are ideally located close to the UK motorway network, rail links and Birmingham International Airport.
Advena Ltd are active members of the European Association of Authorised Representatives (EAAR) who have representatives on most of the major European policy making committees, including those for device vigilance, clinical trials, emerging technologies, IVD devices. Appropriate information from these meetings is reported in our regular client report.
We are also members of West Midlands Medilink.
Advena Ltd holds BSI Certificate No: MD 584849 and operates a Quality Management System which complies with the requirements of ISO 13485: 2003 for European Authorised Representative services, quality management, regulatory affairs and document creation and control for medical device manufacturers.
View our BSI certificate ยป
