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January 2010

Overview of ISO 13485 - Medical Device Quality Management System Requirements

ISO 13485 is a regulatory standard whose focus is meeting customer requirements, including regulatory requirements, and maintaining the effectiveness of the QMS. This differs from ISO 9001:2000 which focuses on customer satisfaction and continual improvement. Whereas both customer satisfaction and continual improvement are as important to medical device manufacturers as to any other business today, these things are hard to measure and tend to be somewhat subjective. So when it came time to adapt ISO 9001:2000 to the medical device industry, these potentially subjective requirements were changed to meeting customer requirements and maintaining the effectiveness of the QMS, which are more easily measureable.

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Data and Content Migrations: Minimizing the Risk

Compliance and business risk plays a significant role in the implementation methodologies of corporate information systems. Further, the compliance and business risks associated with these corporate information systems are, in general, well known. However, as part of the implementation process many of these information systems will be populated with legacy data. The compliance and business risks associated with migrating this legacy data and content into a new system are not necessarily understood. In this context, risks associated with data migrations are a direct result of migration error. Further, industry testing strategies to mitigate such risk, or more specifically data migration error, lack consistency and are far from deterministic. This is the first of two articles that present some thoughts and recommendations on how such a testing strategy can be designed.

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Did you know that the FDA is currently proposing the amendment of regulation 21 CFR Part 803 with the intent of requiring the electronic (eMDRs) submission of postmarket medical device reports?
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