Medical Devices
The Challenge
Medical device manufacturers face tremendous challenges, including stringent regulations, competition, consumer advocate groups, and product liability lawsuits. As a result these manufacturers must create safe and reliable products that perform perfectly, but are still cost effective. In other words, medical device manufacturers have to balance risk, performance and cost.

Between 1992 and 1998, the FDA analyzed 3140 medical device recalls and found that 242 of them were due to software failures. Of those software related recalls, 79 percent were caused by software defects that were introduced when changes were made to the software after its initial production and distribution. The strict guidelines ensure that medical devices reach the public market only after the assurance that quality has been incorporated throughout the lifecycle.
The Dyadem Solution
Dyadem counts hundreds of the worlds leading medical device and biotechnology companies as customers. Dyadem’s solutions and services ensure that medical device companies achieve reduced risk through a comprehensive standard of quality across their global enterprise. Dyadem medical device customers know that achieving high standards of quality, minimizing the risk of defects and reducing process administration is paramount to maintaining industry leadership status in medical research and device production. Dyadem solutions ensure that companies comply with a host of domestic and international quality regulations, including the IVD Directive, CE Marking, ISO 14971 and various Food and Drug Administration requirements in the United States. This includes FDA 21 CFR, Part 11, which regulates the use of electronic records and signatures, a crucial process in medical device manufacturing.

Stature Quality Lifecycle Management
FMEA-Med
PHA-Pro
FTA-Pro
"In our industry, quality and risk management parameters are integrated into all aspects of research, development, production and application, as our products must perform flawlessly. Dyadem's software allows us to work in a more uniform environment, and assess quality in a standard way.”

Genzyme Corporation