Medical device industry ramps up for the CSA Act’s software changes

Change is coming for software development teams at medical device manufacturers through the Computer Software Assurance (CSA) Act.

Carla Neves is quality manager and medical devices product owner at Critical Manufacturing. [Photo courtesy of Critical Manufacturing]

By Carla Neves, Critical Manufacturing

The Computer Software Assurance (CSA) Act of 2022 aims to improve quality and cost-efficiency in validating computer systems for medical device manufacturing. Although it has not been finalized, manufacturers, software developers, and consultants have fully embraced it and are ramping up for implementation.

Transitioning to risk-based validation after more than 20 years of document intense compliance will likely dominate medical device software operations for many years to come, as will building out the manufacturing execution system (MES) infrastructure to support it and developing the innovations that t…

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