Software Program for FMEA Studies Available

Since quality assurance/quality control is so important in the medical device industry, almost all device manufacturers carry a large number of risk analysis or hazards identification studies. Perhaps the most common methodology is an Failure Mode Effects Analysis, or FMEA. Dyadem International has developed a software product just for this purpose.

FMEA For Medical Devices allows manufacturers to examine the failure modes of medical devices and their effects on the surrounding system. Risk analysts can postulate failures, examine effects, record safeguards, and recommend modifications. Most of the features of this product are fully customizable.

FMEA for Medical Devices can help manufacturers create an FMEA study while submitting a 510(k), PMA, or QSR/cGMP report. It can also help with following IEC, MIL, EN or ISO standards. The 32-bit FMEA software product is optimized for Windows 95/98/NT/2000.

For more information, contact Dyadem International Ltd., Medical Device Division, Tel: (905) 940-1600; Fax: 905 940 9090; E-mail: info@dyadem.com. To take a free tour of the software, download it from: http://www.fmeasoftware.com.

Edited by Ursula Jones