Software Validation Iso 13485. Records of such activities shall be maintained. The Software Validation Procedure governs computer systems and medical device software used in medical device development production and QA activities.
Software Validation Wearemaven from medicaldeviceregulations.org
You can buy the ISO 13485 standard. Validation of computer software is specified in section 416 of ISO 134852016. Record of Software Validation.
Activities should be proportionate to risk.
The specific approach and activities associated with software validation and revalidation shall be proportionate to the risk associated with the use of the software. So thats simple you have to do everything that is mandatory in ISO 13485 excepted requirements in chapter 7 with good justifications. Youll need to ensure that your system is working continues to work as expected and meets the requirements of ISO. Record of Software Validation.
