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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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Regulatory News |
MeddiQuest News |
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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 will be a very busy time for MeddiQuest as we will be 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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FDA User Fees for 2008
This year the reauthorization of User Fees went down to the line, but were eventually signed into law
the week before the start of the new fiscal year. FDA are frantically trying to get systems in place to
cope with the numerous changes. The key changes are:
- Reduced Fees for some submissions
- New Fees introduced
- Small Manufacturer Discounts available internationally
Read our view of the changes
ISO 14971 Revision
MeddiQuest's Mariona Casals has been looking at the 2007 revision to the ISO 14971 standard for risk
management of medical devices.
Read Mariona's Report |
We will also 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 IEE 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 February 22, 2008
MeddiQuest Limited: Incorporated in England under number 4226188 at 116-SG8 9DY |