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 documentation as a by-product of the design capture process. As the product development team captures the design, establish relationships, etc., they are also capturing the information that ends up in the design specifications and documentation (complete with requirement traceability back to source requirements and regulations). Because FrameMaker is delivered/integrated with SLATE, medical compliance documentation can be automatically generated and maintained using SLATE (i.e. the documentation automatically reflects the contents of the design database).

  • supporting a "groupware" approach to product design. Just as Lotus Notes š helps groups collaborate together on development of documents, SLATE helps groups of people collaborate on the development of products. SLATEís distributed Object Oriented Database can also support distributed development teams as the database ensures that everyone is working on the latest information where ever they are located around the world. The result is a tool that allows many people to be working together on the same design database at the same time.

  • using itís patented TRAM feature, SLATE includes the ability to capture all aspects of the system (not just hardware or software). Disciplines such as manufacturing, distribution, field support, reliability, safety and others can all be captured and related to the system under design. Because each of these different views can be interrelated, the impacts of changes in one view can be seen throughout. For example, if a requirement drives a particular function and that function is performed by this component and that component is tested by this test set or manufactured by this vendor--the test set or component vendor can see the requirements that affect them.

...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).

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