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| 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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FDA's Extra-Territorial Moves
The Bush Administration, concerned about healthcare and food products from China, is pressurizing for
extra-territorial powers for FDA. Through a new MoU, FDA have also gained access to some of China's SFDA records
and will establish a first "foreign" office in China. Simultaneously concern has been expressed about FDA's world-wide
inspection program and new resources are on their way. The effects will not be limited to China and coupled with additional
inspection resources will be of concern to all medical technology companies.
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Another New Starter!
Susana Martinez Ferrero has joined the MeddiQuest Team. Susana has a degree in Business Administration,
having studied at Complutense University in Madrid and her areas of focus were Finance and Marketing
Management. As soon as she finished her degree she started working in Madrid, Spain for three years
where she got professional expierence in Accounting and Finance. She is fluent in English and Spanish
as well as having a knowledge of Italian. We hope Susana enjoys working with us!
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Major ISO 14971 Conference in London April 29
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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CAD Guidance
FDA's Radiological Devices Panel met early March and formed a consensus on Computer
Aided Diagnostics. FDA are considering the Panel's advice, but in reality this a "done deal"
and a new level I document detailing the types of data necessary to characterize a CAD system
should be issued for comment ... sometime ... soon ... -ish!
MDD Revised
Read our view of the
uninspiring fudge!
ISO 14971 Revision
Neil Armstrong will chair the
CQI MTQG major conference
on the effect of the 2007 revision of the medical device
risk management standard on April 29 in London.
Mariona Casals has been looking at the
2007 revision.
FDA User Fees for 2008
Read our view of the changes
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Susana always wanted to move and work in England and she decided to move to London at the begining
of February 2008. She then joined MeddiQuest at the begining of March 2008.
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
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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 March 24, 2008
MeddiQuest Limited: Incorporated in England under number 4226188 at 116-SG8 9DY
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