Testing & Inspection
Notable Links
Get to know FDA's quality system inspection technique (QSIT). Read the history and mission statement behind the QSIT, then download an overview of the technique. Learn the reasoning behind the reengineering of the inspection process and its effects on medical device manufacturers. As FDA moves closer to global harmonization of testing and inspection guidelines, see how the QSIT will work and what safeguards are in place to ensure this success. In addition, check out the Inspection of Medical Device Manufacturers Final Guidance for Industry and FDA for further information on FDA testing and inspection policies. For an opinion on whether QSIT will meet user needs and intended uses, check out: www.devicelink.com/mddi/archive/00/01/011.html.
Read FDA's complete plan for statutory compliance and see how the plan's objectives affect the medical device industry. Detailed analysis of the objectives provides insight into the philosophy behind FDA's quality system inspection technique.
The official Web site of the Global Harmonization Task Force. Find general background on participating countries, current policies, and additional links where you can find information on the global harmonization of the regulation of medical devices. The site details the roles and responsibilities, guiding principles, operating procedures, structure, and history of the GHTF. Plus, each Study Group section contains thorough information on the evolution of GHTF policy. You'll not only find the final documents, but also the working drafts and proposed documents.
Learn about medical device design, development, and testing from the Bioengineering Department at Southwest Research Institute (SwRI). This independent, non-profit research organization's laboratory carries out performance testing, failure analysis, electrical safety testing, EMC testing, shock, vibration, thermal, and humidity testing, life-cycle testing, and biocompatibility testing. The SwRI lab also has simulation-testing procedures that mimic real-word conditions.
The CDRH site is clearly the first stop for regulatory information. It includes a center overview, recent CDRH federal register notices, blue book memoranda, and much more. Contact information for each department and program area is provided on the CDRH Referral List.
A must see for all things testing, the American Society of Testing and Materials?Web site offers directories for labs and consultants, technical committee information, training courses, QA programs, and news and information. An excellent section on standardization news is also available.
