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On the NHS Digital website I read; "Compliance with DCB0129 and DCB0160 is mandatory under the Health and Social care Act 2012." https://digital.nhs.uk/services/clinical-safety/clinical-risk-management-standards ------------------------------ Kevin Painter Mentor, Medical Device Regulatory Compliance ...

Hello Peter, please look at the newly published MDCG 2021-8. Appendix 6 table B provides a template "Matrix of General safety and performance requirements". It combines your columns 4 and 5, and of course you can have as many columns as you wish, but if you follow the MDCG guidance you can be pretty ...

Thanks for sharing your experience Tim. In which country/CA? ------------------------------ Kevin Painter Mentor, Medical Device Regulatory Compliance Poland and United Kingdom ------------------------------

Thanks. Much appreciated. ------------------------------ Kevin Painter Mentor, Medical Device Regulatory Compliance Poland and United Kingdom ------------------------------

Thanks. I was wondering if there was a delay before receiving your SRN? ------------------------------ Kevin Painter Mentor, Medical Device Regulatory Compliance Poland and United Kingdom ------------------------------