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Challenges and Directions for Lifecycle Processes Supporting Conformity Assessment of Interoperable Medical Products

This article provides an overview of lifecycle issues for interoperable medical products that are not sufficiently addressed in existing medical device standards and identifies lifecycle concepts from other domains that may be adapted for interoperable medical systems.

TÜV SÜD America Authorized to Audit Within the MDSAP Pilot Program

TÜV SÜD America is one of the first auditing organizations (certification bodies) to become...

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