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510(k) Database of new or significantly changed device information submitted by medical device manufacturers prior to commercial distribution.
Adverse Events Reports of adverse events involving medical devices.
Advisory Committees Database of committee meetings that provide independent, professional expertise and technical assistance on the development, safety and effectiveness, and regulation of medical devices and electronic products that produce radiation.
Assembler Database of locations and identities of certified components of diagnostic x-ray systems for routine compliance testing at user facilities.
CFR Title 21 Database of the most recent revision of Title 21 of the Code of Federal Regulations (CFR) from the Government Printing Office (GPO).
Classification Database containing medical device names and associated information developed by the FDA Center for Devices and Radiological Health (CDRH) in support of its mission.
CLIA Database of laboratory testing standards that ensure the accuracy, reliability and timeliness of patient tests.
Guidance Database of documents for CDRH staff, regulated industry and the public that relate to the processing, content, and evaluation of regulatory submissions; the design, production, manufacturing, and testing of regulated products; #chr(1">Guidance</a></p>
PMA Database of Class III devices that support or sustain human life or are of substantial importance in preventing impairment of human health.
Recalls Database of classified medical device recalls since November 1, 2002.
Registration & Listing Database of devices in commercial distribution in the United States submitted by domestic and foreign manufacturers and medical device establishment information submitted by domestic and foreign establishments.
Standards Database of Recognized Consensus Standards with associated FDA, medical device and standards industry information.
DIRECTIVE 98/79/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 27 October 1998
DIRECTIVE 2000/70/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 16 November 2000 amending Council Directive 93/42/EEC as regards medical devices incorporating stable derivates of human bloodor human plasma
DIRECTIVE 2001/104/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 7 December 2001 amending Council Directive 93/42/EEC concerning medical devices
REGULATION (EC) No 1882/2003 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 29 September 2003 adapting to Council Decision 1999/468/EC the provisions relating to committees which assist the Commission in the exercise of its implementing powers laid down in instruments subject to the procedure referred to in Article 251 of the EC Treaty
