What is the design control process and how has it changed?

[@SarahAlGafry]

Hi Rob, thank you for another great educational video for MD professionals, my question is: If Device Master Record (DMR) in the US is equivalent to technical files in the EU, what would be the equivalence to Design History File (DHF) in the EU? Does this mean that the technical file will include both the DMR and the DHF? Please advise, as it is a bit confusing.

[@MedicalDeviceAcademy]

Hi Sarah, Thank you for the positive feedback. There is no equivalent definition for a "Design History File" in other regulations. However, in all countries you are required to establish and maintain records of your design and development projects. Therefore, even though the EU doesn't have a definition or acronym for it, you have always been required to maintain a DHF for Europe. Under the MDD, it was called a Design Dossier. The term is now obsolete, but the requirement to have one is not. Under the MDD, the Design Dossier was only reviewed for Class 3 devices, but all devices has to maintain those design records. Rob

[@SarahAlGafry]

@@MedicalDeviceAcademy very well explained. thanks

[@edpalen5295]

isn't it 13485 instead of ISO 1345?

[@MedicalDeviceAcademy]

The particular video you commented on is actually about IEC 62304 and how design controls have changes as agile has be adopted. Most companies now think in terms of the V-diagram instead of the Waterfall diagram for software development. You are correct that the quality system standard is ISO 13485:2016, but I think I probably did not say it clearly enough or spoke too quickly. I also referenced ISO 9001:2015 which is a general quality system standard.

[@imedzavani3759]

Rob! The Best as always :)

[@MedicalDeviceAcademy]

Thank you.