July 6, 2021 EU MDR Critical Component Changes to MDD-Installed Devices If changing the supplier of a critical component that will be, or could be, subsequently used for component replacement in devices already installed (i.e., already put into service) in the Union prior to 26 May 2021 under an MDD Declaration of Conformity (DoC) […]
<h1 class="entry-title">Author: <span class="vcard">Kevin Randall</span></h1>
Health Canada CMDR Updates 2021
June 28, 2021 Health Canada CMDR Updates 2021 Here’s a quick recap of Health Canada’s changes to the Medical Devices Regulations (SOR/98-282) that started coming into force on 23 June 2021: Effective 23 June 2021, Health Canada has additional authorities to require us to do certain analyses and make certain information available to […]
EU MDD and MDR “AFAP”
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 […]
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U.S. FDA releases draft guidance on submission requirements for management of medical device cybersecurity
October 2018 U.S. FDA releases draft guidance on submission requirements for management of medical device cybersecurity… Links to the draft guidance and corresponding Federal Register notice are provided below: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