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MeddiQuest Limited |
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Regulatory Affairs Management |
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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 Directive (MDD: 93/42 EEC) Revised
In March 2010 the 2007/47/EC revisions to the Medical Devices Directives (93/42/EEC) finally took effect. The impact of the explicit inclusion of software and the need to review machinery and PPE directives' essential requirements still seem to be causing interpretation issues for some manufacturers.
Read our view of the changes
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RAPS Conference and
ComPaMED Exhibition
The Fall has been a very busy time for MeddiQuest as we were exhibiting at the RAPS Conference and Exhibition in San Jose, CA, USA in October and then at ComPaMED in Duesseldorf in November.
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Click above for new events
RAPS on-line university and RAC certification are major pillars of our profession
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 MeddiQuest's National and International Strategic Partners
MeddiQuest's EU Authorized Representative Service
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De-Harmonization
The European Commission has proposed deharmonizing certain standards so that they no longer give an automatic presumption of compliance with the essential requirements of the medical devices directives. Critically ISO 14971, the medical device risk management standard is amongst these, despite the fact it is explicitly required in ISO 13485 harmonized quality management standard. So medical device manufacturers may be faced with having to still comply with ISO 14971 in order to be able to meet ISO 13485, yet not being able automatic compliance with the essential requirements related directly to risk management. The issue seems to be standards based on sound principles, like 9001 and 14971, do not meet the "letter" of regulations drafted by lawyers, translated and others not skilled in the underlying discipline. Another coup for bureauocracy over common-sense?
ISO 14971 Revision
MeddiQuest's Mariona Casals has looked at the 2007 revision to the ISO 14971 standard for risk
management of medical devices.
Read Mariona's Report |
We will be celebrating our tenth birthday by launching our business services as a "spin-out" business unit. MeddiQuest Business Services will be focusing on support for: acquisitions, mergers and disposals as well as national and international agencies and marketing activities - for more information please visit meddiquest.biz
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:
- 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"
Read about the new greener MeddiQuest |
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.
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 email us at info@meddiquest.com
Uploaded March 20, 2005 - Last updated December 05, 2010
MeddiQuest Limited: Incorporated in England under number 4226188 at BioPark AL7 3AX
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