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
The European Commission's Proposal for the reworking of the Medical Devices Directives into two Regulations is still before the European Parliament. During the "report" stage our Neil R Armstrong met with the shadow Rapporteur as part of the regulators affairs profession contribution.
Now we all just need to wait what the Parliament will forward to the Council!
MeddiQuest will be exhibiting for the first time at Mediplas
, the medical plastics exhibition at the NEC in Birmingham which runs from 25 to 26 September 2013
on stand J12
As you can see from the photograph below, our Business Development Executive is already waiting patiently for you on our stand!
Our Neil R Armstrong and James Love are officers if the CQI MTQG.
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
- Notified Body Consistency
- Centralization and Consistency of AIRs
- Improved borderline issue management
- Responsible Person
- Improved transparency
- Improved traceability
- Increased clinical input
- Import Management
- Increased Eurocrats
- Classification and ER Review
- IVDs to come into line
Andrea Hermosa is the first designer to join our permanent team. Andrea has a dual role: working with our customers on ergonomics, design documentation and risk projects, as well as helping the development of the new Quest Science businesses.
Andrea is a keen photographer ... so we look forward to some more inspired photos on our website!
Our New Home!
We have finally moved into our new home, Quest Science at Herlington House in Orton Malborne. Chosen for its easy of access to
the A1(M), East Coast Main Rail Line and London Airports, our new building gives us opportunities 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 60% reduction in air-tansport pollution
- a 70% reduction in paper use
- a new sustainable business to help others go "greener"
Neil lectures on the TOPRA MSc Courses at Cranfield University in Medical Technologies Regulatory Affairs and the University of Hertfordshire Pharma MSc Medical Technologies module. Andrea is currently studying the e-learning business modules.|
MeddiQuest is a member of the IET Healthcare Technologies Network.
email us at email@example.com
Uploaded March 20, 2005 - Last updated September 03,2013|
MeddiQuest Limited: Incorporated in England under number 4226188 at BioPark AL7 3AX