January 26, 2021 EU MDD and MDR “AFAP” Check Your Existing Procedures: To properly attend to what Europe’s outgoing Medical Devices Directive (MDD) and new Regulation 2017/745 (the EU MDR) require regarding the reduction of risk “as far as possible” (AFAP), it is first important to know what an organization’s corresponding acronym actually […]
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FDA & ISO DMR/MDF vs. “Design Output”
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 […]
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U.S. FDA releases draft guidance on submission requirements for management of medical device cybersecurity
October 2018 U.S. FDA releases draft guidance on submission requirements for management of medical device cybersecurity… Links to the draft guidance and corresponding Federal Register notice are provided below: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
From the Archives: Final draft of New ISO 13485 Medical Devices Quality Management System Standard published…
October 2015 For several years ISO 13485:2003 (which is the heart of BS EN ISO 13485:2012) has been under revision. After incorporation of numerous comments and feedback from many international stakeholders, a final draft of the standard has now been released by ISO Technical Committee 210. It is expected that the final standard will […]
Status of revisions to the European Medical Devices Directive…
September 2015 For updates from the European Commission regarding revision of the European MDD, click the link below: http://ec.europa.eu/growth/sectors/medical-devices/regulatory-framework/revision/index_en.htm
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