October 13th, 2017

PRE-RECORDED WEBINAR: Deep Dive into the impact of the changes to the EU Medical Device Regulations – A Notified Body Point of View

This webinar was delivered live on 12th Oct 2017. 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 have already seen a significant decrease in the total number of Notified… read more

September 28th, 2017

PRE-RECORDED WEBINAR: Writing HFE Reports for Submission to FDA

Since the late 1990s, FDA has expected Class II and III medical device manufacturers to apply human factors engineering (HFE) comprehensively to help reduce the chance of harm due to use errors. In 2016, FDA updated its HFE guidance to industry, specifying that submissions should include an HFE Report if the associated device requires users… read more

September 20th, 2017

What you need to know about MDSAP

With the clock ticking on Health Canada’s January 2019 deadline for medical device manufacturers to move from the Canadian Medical Device Conformity Assessment System (CMDCAS) to the Medical Device Single Audit Program (MDSAP) there is still a lot to learn about the program. Here are a few of the top questions UL’s MDSAP certification experts… read more

August 28th, 2017
August 17th, 2017
PRE-RECORDED WEBINAR: Be ready for Canada’s 2019 transition from CMDCAS to MDSAP
August 3rd, 2017
PRE-RECORDED WEBINAR: IEC 60601-1 Amendment 1 and Risk Management
July 31st, 2017
UL Live Webinars: Deep Dive into the impact of the changes to the EU Medical Device Regulations; How to prepare for new EU MDR Requirements for Clinical Evaluation and Technical Documentation;
July 21st, 2017
PRE-RECORDED WEBINAR: Business Impact of the new EU Medical Device Regulation – An Executive Briefing
July 4th, 2017
PRE-RECORDED WEBINAR: Meeting new FDA Expectations for ISO 18562 VOC and Particle Testing for Medical Devices
July 4th, 2017
PRE-RECORDED WEBINAR: Medical Device Use Error – Root Cause Analysis