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In addition, the authors of MDCG 2019-11 emphasize the significance of rule 3.5 in Annex VIII of the MDR, which simply states that the strictest rule applies ought to something be unclear. Guidelines 3.3 and 3.5 are also equivalent to in-vitro diagnostics in rules 1.4 and 1.9 in Appendix VIII of the IVDR.

1. Examine all the choices; Built-in Suite versus Best-of-Breed, Cloud-based mostly versus On-premise. Which mixture can finest complement your finances? Notice that improve charges, server costs, training charges, and help fees may be part of the solution that you are about to select. Weigh all these options towards your company’s price range and needs.