FDA CSA Regulatory Requirements - All you Need To Know

 

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fda-csa-regulatory-requirements


Interesting article from Compliance Group Inc related to Computer Software Assurance (CSA) and Computer Software Validation (CSV) in the context of FDA regulatory requirements. CSA and CSV are critical aspects of ensuring the safety, reliability, and effectiveness of software used in medical devices. While there are no specific FDA regulations solely dedicated to CSA and CSV, compliance with Quality System Regulation (QSR) under 21 CFR Part 820 is essential for medical device manufacturers. This article addresses key questions on implementation, tools, consequences of non-compliance, outsourcing, and additional resources for CSA and CSV, providing valuable insights for manufacturers navigating software assurance and validation in the medical device industry.


Citations:

FDA CSA Regulatory Requirements | 21 CFR Part 11 | Compliance Group Inc

21 CFR Part 820 vs ISO 13485 | Compliance Group Inc

CSA (vs) CSV: Understanding the Key Steps of Validation Process (complianceg.com)


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