MeddiQuest Limited
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!
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Medical Device Regulation

The Medical Device Regulations (EU) 2017/745 and 746 have now been published will become numbers to fear!- no mean political achievement, but alas there are plenty of flaws in a regulation of disproportionate complexity to the issues it attempts to resolve.
The regulation is still hardware-centric and the little language in the draft addressing software has been removed - overall this means that the regulation is better suited to the medical devices of the last century than the innovative new products of the next decades.
The issues around reuse of SUDs has been fudged to allow member states to do anything they like and the tightening of controls seems to do more and the wholesale reclassification of ingested devices into the highest category irrespective of risk is likely to bring the new regulation into disrepute.
See Neil's Blog.
Standards Nightmare
 
Not only are we still smarting under DG SANCO's rewrite of ISO 14971 to a slavish letter-of-the-law interpretation of the directive, but now ISO TC 210 has accepted DIS 3 so ISO 13485 will not follow the Annex SL format, which is used for all other management system standards including ISO 9001:2015 - when will the regulators stop trying to fiddle standards to suit their needs rather than accept the sound quality philosophy underlying the standards process? This will force many device companies to drop ISO 9001. How sad to see quality principles being compromised by the regulators who claim to value them! Come and talk to use about your quality and risk issues
RAPS on-line university and RAC certification are major pillars of our profession
 
Neil lectures on the TOPRA MSc Courses in Medical Technologies Regulatory Affairs.
MeddiQuest's National and International Strategic Partners
 
MeddiQuest's EU Authorized Representative Service
Armstrong: Comments will change the future

Key Proposals
  • 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

Trumping User Fees

The Trump Administration is proposing to double User Fee receipts from USD 1.2 to 2.4 Billion, on average doubling drug and device user fees. So if you were thinking of a complex US Submission, getting it in quickly could save you thousands!
Our New Home!

We have finally moved into our new home, Quest Science at Herlington House in Orton Malborne, Cambridgeshire. 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 Team Building
The MeddiTigers became MuddiTigers to take part in the 2015 Yorkshire Tough Mudder as our annual team building exercise. What could be more fun than being frozen, wet, electrocuted and running a ten mile assult course? Maybe something easier like a triathlon next year! Hey, special credit to Ivan, because even though he left us a few years ago, he still came back ... he will know better next time!
MuddiTigers
 
MeddiQuest is a member of the IET Healthcare Technologies Network.
 
Site Map Devices InVitro Diagnostics Software-Substances Combination Products
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email us at info@meddiquest.com
Uploaded March 20, 2005 - Last updated June 6, 2017
MeddiQuest Limited: Incorporated in England under number 4226188 at Quest Science PE2 5XS