April 1, 2019 FDA & ISO DMR/MDF vs. “Design Output” Remember that the DMR is intrinsically linked to the design control process. The DMR is by formal definition a design output (see my preceding blog post). It unequivocally lives and breathes in direct relationship to the design control process. A properly-maintained DMR never becomes decoupled […]
<h1 class="entry-title">Author: <span class="vcard">Kevin Randall</span></h1>
FDA & ISO 13485 Design Outputs and the DMR
FDA & ISO 13485 Design Outputs and the DMR Remember that for FDA-regulated firms, design output is formally defined in 21 CFR 820.3(g) as, “…the results of a design effort at each design phase and at the end of the total design effort. The finished design output is the basis for the device master record. […]
U.S. FDA releases draft guidance on submission requirements for management of medical device cybersecurity
October 2018 U.S. FDA releases draft guidance on submission requirements for management of medical device cybersecurity… Links to the draft guidance and corresponding Federal Register notice are provided below: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM623529.pdf https://www.federalregister.gov/documents/2018/10/18/2018-22697/content-of-premarket-submissions-for-management-of-cybersecurity-in-medical-devices-draft-guidance