SLATE Application to Medical Device Development and Qualification
With the Safe Medical Devices Act of 1990, congress introduced the first comprehensive legislation to cover medical device industry in 14 years. It establishes new requirements for manufactures to ensure that products that enter the market are safe and effective, particularly in the areas of pre-market approval and post surveillance. For example, pre-market notifications, commonly referred to as 501 (k)s, for certain types of medical equipment must include a summary of safety and effectiveness data or state that such information is available upon request. The law also requires that for high risk devices introduced after 1990, manufacturers must conduct post-market surveillance. The FDA also may require post-market surveillance for any other device if the agency believes this action is necessary to protect public health.
The law also calls for stricter FDA enforcement. Manufacturers that are not in full compliance with specified good manufacturer practices may face civil penalties, recalls or cessation of shipments. All of which brings new impetus to knowing what the regulations and requirements are and how they are addressed by the medical device.
SLATE represents a new approach to managing regulatory compliance for the medical device industry by providing a means of capturing the regulations and requirements and graphically relating them to the device architecture. As shown below, this not only includes the hardware or software components, but also the manufacturing, testing and other development processes.
In addition, SLATE provides a means of accelerating product development and approval by:
...creating a living representation of the decisions, problems, issues, and other important information captured in the context of the medical device. All of which sets up a means for achieving product reuse on a chunk of project basis (the same power supply we used on last years model, were using on this years model--complete with traceability to the regulations/requirements that drive it).
© 2000 SDRC. All Rights Reserved.
@ 2000 KFKI ISYS Informatikai Kft.