Software Process And Documentation Assessments

Process Assessments/Audits
Providing 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

​Reviewing 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.



If you are interested in obtaining more information about our Software Process Assessments and Audits, please provide us with your contact information and we will get back to you right away.