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Software verification and validation services
Medical device software, whether a standalone device or a programmable component of a medical device should be designed, programmed and tested in compliance with international harmonized standards and national guidelines. Software validation should be performed using software QA procedures and complete software life cycle should be documented while managing changes and versions. Furthermore, medical device software traceability should be maintained and the information should be placed into validation protocol templates. Software verification should be demonstrated by applying the appropriate software testing tools. For instance, FDA’s software guidance, compliance to 21 CFR Part 11, IEC60601-1-4 and others.
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References
- IEC 60601-1-4:2000 Consol. Ed. 1.1, Medical electrical equipment - Part 1-4: General requirements for safety -- Collateral standard: Programmable electrical medical systems, edition 1.1. (General)
- EN / IEC 62304 as standard for Life Cycle Requirements for Medical Device Software
- Guidance for Industry and FDA Staff - Guidance for the Content of Pre-market Submissions for Software Contained in Medical Devices, May 11, 2005
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff, January 11, 2002
- Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices; Final, September 9, 1999