April 4, 2023 Can the EU MDR PMS Procedure and PMS Plan be the Same Thing? Part 2 Carrying on from the first part of this topic from a couple days ago: Indeed, it is wise to stick with longstanding principles and corresponding normative requirements for medical device QMS documentation. And it’s essential to […]
Can the EU MDR PMS Procedure and PMS Plan be the Same Thing? Part 1
April 3, 2023 Can the EU MDR PMS Procedure and PMS Plan be the Same Thing? Part 1 The MDR/IVDR PMS procedures and blank templates for the PMS Plan should be Tier 2 generic quality management system (QMS) documents (i.e., procedures), while the actual PMS Plan should instead be a device-specific Tier 4 QMS […]
Can a Customer Survey Be Used as Part of PMCF?
July 30, 2021 Can a Customer Survey Be Used as Part of PMCF? PMCF may not need to be full-blown prospective clinical investigation. Specifically, I would place such goals under the banner of the general types of non-investigational PMCF that I’ve mentioned before in my prior PMCF post(s). Indeed, such feedback could certainly be […]
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 […]