Article: Massachusetts Biotech, Medical Firms Hail Speeding Up FDA Reviews.(Originated from The Boston Globe)

Article: Proposed Changes At FDA And Proposed Legislation Threaten ...
Mondaq Business Briefing;  March 25, 2009 ;     700+ words ... ... approval of a new medical device, rather than ... which seeks FDA approval by showing ... approved by the FDA. Many in the medical device community were ... effective by the FDA was not granted ... passage of the Medical Device Safety Act ...

Article: Medical device makers find solution to FDA ...
Tooling & Production;  December 1, 2007 ;     700+ words ... ... Change controls: The FDA expects all medical device companies to maintain ... Material controls: The FDA requires that medical device companies maintain a ... facility controls: The FDA requires medical device companies to establish ...

Article: What every foreign OEM, importer should know: a review of ...
Medical Product Outsourcing;  July 1, 2009 ;     700+ words ... ... in the way that FDA conducts foreign medical device inspections between ... focus is given to FDA warning letters involving foreign medical device manufacturers over ... detailed information on medical device inspections that the FDA conducted between ...

Article: FDA Medical Device Trade Updates for Nephros ...
M2 Presswire;  June 8, 2009 ;     700+ words ... ... 2009-BiomedReports: FDA Medical Device Trade Updates for Nephros ... initial article on extreme FDA trades on pending medical device decisions. NEPH.OB still ... 1174-seven-extreme-fda-medical-device-trades.html Biotech ...

Article: MatrixOne Introduces its Accelerator for FDA Compliance; A ...
Business Wire;  November 17, 2003 ;     700+ words ... ... s Accelerator for FDA Compliance provides medical device manufacturers with ... Companies in the medical device industry must ensure FDA compliance throughout ... MatrixOne Accelerator for FDA Compliance allows medical device manufacturers to ...

Article: FDA Speakers to Discuss Medical Device and ...
PR Newswire;  April 27, 2005 ;     700+ words ... ... The North Carolina Medical Device Organization (NCMD ... Administration (FDA) speakers who will ... Panelists at the NCMD Medical Device Forum include the ... Associate Director, FDA, Office of Combination ... CDRH Ombudsman, FDA, Center for Devices ... registration for the May ...

Article: Streamlining quality assurance and FDA compliance: ...
Medical Design Technology;  May 1, 2005 ;     700+ words ... ... Title 21 of the FDA's Code of Federal ... most successful medical device companies with electronic ... signatures. While the FDA does not mandate ... 21 CFR Part 11, medical device companies that transform ... well as the risk of FDA non-compliance ... regulatory approval. ...