On Wednesday – August 16th 2017, Deborah Stubbs, Staff Engineer, Lead Auditor, UL and Michael Windler, Global Regulatory Manager, UL presented a live webinar on Canada’s 2019 transition from CMDCAS to MDSAP. The Medical Devices Single Audit Program (MDSAP) was created by the International Medical Device Regulators Forum (IMDRF) to allow manufacturers to meet the... read more
About this webinar: The fourth edition of IEC 60601-1-2, a collateral standard that provides the requirements for essential performance and basic safety in the presence of electromagnetic disturbances was published in early 2015. Requirements for documentation, technical descriptions, user information, in addition to emissions limitation and susceptibility performance, are outlined in the standard. Major changes... read more
Deep Dive into the impact of the changes to the EU Medical Device Regulations – A Notified Body Point of View The European Commission has recently published the new Medical Device Regulations which introduce new and more extensive requirements on manufacturers, Notified Bodies and other economic operators. Because of the scrutiny and re-designation requirements, we... read more
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