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Software Process And Documentation Assessments


Process Assessments/Audits
We provide Process Assessments/Audits for compliance/conformance to industry standards

and FDA guidance:

- ANSI/AAMI/IEC 62304:2006 - Medical Device Software - Software Life Cycle Processes
- FDA General Principles of Software Validation; Final Guidance for Industry and FDA Staff (2002)
- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005)
- FDA Off-The-Shelf Software Use in Medical Devices (1999)

- ANSI/AAMI/IEC TIR 80002-1:2009 - Medical Device Software - Part 1: Guidance on the application of ISO 14971 to medical device software

- 21 CFR Part 820.30 - Quality System Regulation - Design Controls

​- ISO 13485 - Medical devices — Quality Management Systems – Product Realization


- 21 CFR Part 11 - Electronic Records; Electronic Signatures

- AAMI TIR 36:2007 - Validation of software for regulated processes


​We will review your current practices with regard to the regulations, standards, and guidance listed above and will provide a written report detailing the assessment and making recommendations where warranted.


MEDICAL DEVICE SOFTWARE DEVELOPMENT CONSULTING