Below are links to other websites you might find useful
Please click on the appropriate logo on the left to go to the website. The link will open in a new window.
Medical Devicelink is published by Canon Communications LLC (the folks of the Medical Design & Manufacturing exhibition fame) and is loaded with excellent information.
Mr. Al Weisenborn runs the Medical Device Forum, an Internet based forum for a wide diversity of topics regarding medical devices and equipment. This website also contains many links to other sites of interest.
Mr. Jon Griver publishes 601Help, "The Medical Device Developer's Guide to IEC 60601-1", a very useful site addressing a variety of topics around IEC 60601-1, the "general" safety standard for medical devices.
OCRA, The Orange County Regulatory Affairs Discussion Group, is one of the most active associations of Regulatory Affairs professionals in the country. Their meetings are known meeting places of FDA officials and industry representatives.
The FDA issues new regulations and documents continuously.
CDRH, the Center for Devices and Radiological Health, is the division of the FDA that applies FDA's regulations for medical devices. On this website one can find all publicly available information including the Office of Device Evaluation (ODE) information.
The ISO (International Standards Organization) and its sister organization, the IEC, publish many standards that are of interest to the medical community. The ISO is famous for its quality standards: the ISO 9000 series is the "grandfather" of Quality Assurance. Please pay attention to ISO 13485:2003, the new standard detailing the application of ISO 9000 concepts to medical device companies. The ISO also publishes biological test standards.
The IEC (International Electrotechnical Committee) publishes safety standards for medical devices. Although these standards were originally electrical only, today's safety standards include electrical, mechanical, and software topics.
The Life Science Industry Council (LINC) is an organization promoting the growth of the biomedical industry in Orange County. LINC has recently merged with the Southern California Biomedical Council, focused on the life science industry in the Greater Los Angeles area.