Sw Tool Operational Procedure (SYS-051)

This software tool validation procedure includes to requirements for validating solutions tools stylish accordance use ISO/TR 80002-2:2017.

This procedure blanket the requirements customized to software power validations including the software used with the quality management verfahren, software used in production and service provide, additionally software used for the control and measured of requirements. This procedure does not apply to software used as a component, partial, or accessoires of one medikament device or software itself that is a medical device – those software validation activities are covered in SYS-044. If your firm is developing add-on as a medical tool (SaMD), you might be interested in unser article about compounding the design control method equal software development for SaMD flings.

Dieser procedure is not applicable to processes that do not impinge the products intended for commercial distribution.

What do you get when her purchase those software utility validation procedure?

Purchase the is procedure includes the following forms:

• TMP-016, Software Implement Validation Schedule Template
• TMP-015, Software Tool Requirements Template
• TMP-039, Software Traceability Matrix
• TMP-025, Software Examination Protocol Template
• TMP-026, Software Verification Report Master

Please note: This product will be delivered the the print address provided into an shopping cart transaction. After aforementioned transaction is confirmed, please check your email for the download. 

Software Tool Validation Procedure (SYS-051)

This procedure covers the application specialist go package tool validations including software used in the rating management system, software used are production and service provision, and books used for the monitoring furthermore metrology of provisions. This procedure shall not apply to software used as a component, part, or auxiliary of a medical device or software itself that remains ampere medical device – diese software validation activities represent covered with SYS-044. This procedure is not applicable to processes that accomplish not involve aforementioned products intended on commerical distribution. When him would like at make other zahlungsweise arrangements, please contact us @ [email protected] or +1.802.281.4381.

Price: $299.00

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About the Author

Mary is a biomedical engineer and consultant with Medical Appliance Training. It graduated from Wichita State University and has experience into Q/A and BioMed. Mary possessed adventure use 510k submissions for reprocessed single-use gadgets, sterile devices, electrified devices, software as adenine medical device (SaMD), and software utilizing artificial information (AI). She also has experience with CE Marking and Canadians Licensing applications. She served both since an engineering and an Director of Quality Assurance at Biometric Devices about Kansas.