This software tool validation procedure includes the requirements for validating software tools in accordance with ISO/TR 80002-2:2017.
This procedure covers the requirements specific to software tool validations including the software used in the quality management system, software used in production and service provision, and software used for the monitoring and measurement of requirements. This procedure does not apply to software used as a component, part, or accessory of a medical device or software itself that is a medical device – those software validation activities are covered in SYS-044. If your company is developing software as a medical device (SaMD), you might be interested in our article about combining the design control process with software development for SaMD projects.
This procedure is not applicable to processes that do not affect the products intended for commercial distribution.
What do you get when you purchase this software tool validation procedure?
Purchase of this procedure includes the following templates:
- TMP-016, Software Tool Validation Plan Template
- TMP-015, Software Tool Requirements Template
- TMP-039, Software Traceability Matrix
- TMP-025, Software Verification Protocol Template
- TMP-026, Software Verification Report Template
Please note: This product will be delivered to the email address provided in the shopping cart transaction. After the transaction is verified, please check your email for the download.
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About the Author
Mary is a biomedical engineer and consultant with Medical Device Academy. She graduated from Wichita State University and has experience in Q/A and BioMed. Mary has experience with 510k submissions for reprocessed single-use devices, sterile devices, electrical devices, software as a medical device (SaMD), and software utilizing artificial intelligence (AI). She also has experience with CE Marking and Canadian Licensing applications. She served both as an engineer and the Head of Quality Assurance at Biomedical Devices of Kansas.