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gp232@njit.edu replied to the topic Discussion Topic: Supplemental on DHF and DMR in the forum Introduction to Design Controls 8 years, 3 months ago
Design controls may not be required for Europe, however they can come in very handy with the Design Dossier or Technical File. Logging the development process is good practice and should be done regardless if it is required. If the company is US based and starting up an office or sub-company in Europe, it would be wise to adapt to the European Dossier and Technical file while incorporating practices of the DHF and DMR.