Regulatory Affairs Management|
Welcome to the MeddiQuest website - your first stop on the path to
CE Marking, 510(k) clearance, PMA / PDP Approval and ISO 13485 / ISO 14971 Quality Systems! Make Regulatory
Compliance part of your Competitive Advantage! |
European Commission's Proposals for Recast of Medical Device Regulation
Just as we were preparing for the 2007/47/EC review of the Medical Device Regulations, the Commission dropped the bombshell that a major ReCast was proposed. Finally, years later than planned the Commission's proposals
to the Parliament saw the light of day on September 26 ,2012.
Read Neil R Armstrong's review of the changes
- Will they totally disrupt the industry?
- Are the so watered down as to achieve nothing?
- Do they represent a major contribution to safety?
After two years MeddiQuest will be returning to ComPaMED
at Medica in Duesseldorf. The Exhibition runs from 14 to 16 November 2012 and we will be in Hall 8a stand C30
As you can see from the photograph below, our Business Development Executive has been waiting patiently for our return!
Click above for new events
RAPS on-line university and RAC certification are major pillars of our profession
MeddiQuest's National and International Strategic Partners
MeddiQuest's EU Authorized Representative Service
ICT central to ReCast
- Notified Body Consistency
- Centralization and Consistency of AIRs
- Improved borderline issue management
- Improved transaprency
- Improved traceability
- Increased clinical input
- Import Management
- Increased Eurocrats
- Classification and ER Review
- IVDs to come into line
The EC ReCast of medical device regulation relies on Information Technology for implementation; MeddiQuest's Nikolina Lepich asks if this is wise against EU and UK history of ICT projects.
Read Nikolina's Report
Our New Home!
After year's of searching we are finally completing the purchase of our new facility which will enable us to co-locate all our group companies and give us the room expansion we need! Chosen for its easy of access to
the A1(M) as well as the East Coast Main Rail Line and London Airports, our new building will give the opportunity to develop our services to the Healthcare community. We are really excited about the opportunities to
offer our customer a true "one-stop shop" for health technology support and looking forward to building links with our neighbours in the local community.
MeddiQuest Sustainability Initiative
MeddiQuest was one of the first companies to take advantage of FDA's e-copy 510(k) programme and the
benefits of having paperless office are now really starting to show! We are now a year into our
sustainability initiative and there is a "greener" feel to the business:
Read about the new greener MeddiQuest
- company bikes and skates
- a new more efficent dielsel truck
- a 40% reduction in air-tansport pollution
- a 90% reduction in paper use
- a new sustainable business to help others go "greener"
TOPRA MSc Course at Cranfield University in Medical Technologies Regulatory Affairs about to see its first graduates|
MeddiQuest is a member of the IET Healthcare Technologies Network.
MeddiQuest is a member of Medilink East Midlands.
email us at firstname.lastname@example.org
Uploaded March 20, 2005 - Last updated September 27, 2012|
MeddiQuest Limited: Incorporated in England under number 4226188 at BioPark AL7 3AX