Validation requirements for 13485

According to the ISO 13485:2016, requirement 7.5.6 Validation of processes for production and service provision, processes that need to be validated are processes where the resulting output can not be verified by subsequent monitoring and measurement. As far as I understand your process, if you measure your device after the molding (eg. weight, height, shape, volume or similar) and during assembly, you can clearly see that medical device is properly assembled, that there is no need to validate that part of the process. However, you need to validate the start of the molding process, when temperature and pressure have to be adjusted so that the medical device of proper characteristics can be achieved. If your machine for molding has some software and if you get a new version of the software for that machine, that for the new version you need to be sure that it did not change the final product. 

For more information on validation, you can see the following articles:

• Using ISO 13485 to manage process validation in the medical device manufacturing industry https://advisera.com/13485academy/blog/2017/09/07/using-iso-13485-to-manage-process-validation-in-the-medical-device-manufacturing-industry/
• Production and service provision process in ISO 13485 - https://advisera.com/13485academy/blog/2017/12/13/production-and-service-provision-process-in-iso-13485/

On the following links you can see how certain templates look like in our ISO 13485:2016 Documentation toolkit:

• Record of Software Validation - https://advisera.com/13485academy/documentation/record-of-software-validation-iso-13485-2016/
• Validation Report - https://advisera.com/13485academy/documentation/validation-report-iso-13485-2016/