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. 

Simply contact us for any assistance you may need for your software validation and verification, training, step by step guidance, software QA procedures, V&V templates, online consulting. You may also outsource our complete services of medical software validation and verification activities.

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