December 26th, 2017

PRE-RECORDED WEBINAR: Package validation as per ISTA 2A and Packaging test as per ISO 11607-1

Medical devices delivered in a sterile state must be designed, manufactured, and packed to ensure they are sterile when placed on the market. However, device packaging can degrade over time or become compromised during packing, transportation, distribution, storage or handling. Many device regulators require medical device shelf-life and package testing to the ISO 11607 series… read more

November 8th, 2017

PRE-RECORDED WEBINAR: How to prepare for new EU MDR Requirements for Clinical Evaluation and Technical Documentation

The clinical evaluation is an essential part of the technical documentation, which manufacturers are required to use to document their compliance with the general safety and performance requirements. The new medical Device Regulations places greater emphasis on the use of clinical data to demonstrate compliance with the general safety and performance requirements. And for certain… read more

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
September 20th, 2017
What you need to know about MDSAP
August 28th, 2017
PRE-RECORDED WEBINAR: IEC 60601-1-2 EMC
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