August 10, 2018

RECORDED WEBINAR: Medical Device Cybersecurity UL 2900 – Mitigating Safety and Performance Risks

Q1 Productions recorded webinar lead by UL’s Anura Fernando The Q1 Productions hosted webinar featured guest speaker, Anura Fernando, discussing the FDA recognized 2900 standard and its impact on medical device manufacturers and healthcare. With cyberattacks on healthcare on the rise, the discussion looks at how infrastructure is being targeted and the nuances of security… read more

July 23, 2018

RECORDED WEBINAR: IEC 60601-1-2, 4th Ed, Manufacturers Responsibilities

This webinar was delivered live on 21st June 2018. While the standard IEC 60601-1-2, 4th Ed does change some of the test values, other changes in the standard place an additional responsibility on the manufacturer. This additional responsibility can lead to delays when submitting to the test lab. The manufacturer needs to understand the additional… read more

February 12, 2018

RECORDED WEBINAR: Strategy for Biological Safety Evaluation of Medical Devices

Biological safety evaluation of medical devices is a part of regulatory requirement. The scope of the webinar is to understand the strategy behind the biocompatibility testing and a step wise approach to implement biocompatibility requirements. The topics covered are as follows: Biocompatibility strategy Role of material characterization Biocompatibility studies and Toxicology risk assessment   Register… read more

December 26, 2017

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 8, 2017

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 13, 2017

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 28, 2017

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 20, 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 28, 2017

RECORDED WEBINAR: IEC 60601-1-2 EMC

About this webinar: In 2015 the International Electrotechnical Commission (IEC) published 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. The standard introduces electromagnetic (EM) environments of “intended use”, including professional healthcare facilities and home healthcare. UL’s EMC experts… read more

August 17, 2017

RECORDED WEBINAR: Be ready for Canada’s 2019 transition from CMDCAS to MDSAP

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

August 3, 2017

RECORDED WEBINAR: IEC 60601-1 Amendment 1 and Risk Management

About this webinar: The  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. In this recorded webinar from June 11th, 2015, UL 60601 expert, Mark Leimbeck discusses the major changes introduced by the IEC in the amendment 1 of IEC 60601, including the… read more

July 31, 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;

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

July 21, 2017

RECORDED WEBINAR: Business Impact of the new EU Medical Device Regulation – An Executive Briefing

The UL Health Sciences team is pleased to welcome Dr. Itoro Udofia to UL as our new Head of Notified Body. We are excited to be able to share the 20 years of experience and knowledge to our customers that he brings to UL. On Thursday, July 20th, 2017 Dr. Udofia presented a live webinar… read more

July 4, 2017

RECORDED WEBINAR: Meeting new FDA Expectations for ISO 18562 VOC and Particle Testing for Medical Devices

US FDA 510(k) submissions must include data regarding biocompatibility of any patient contacting materials (directly or indirectly) on all medical devices. For respiratory and ventilation devices, a key component of the biocompatibility evaluation is measuring chemicals and particles that may be released into the breathing gas pathway. Until recently, only general guidance was provided to… read more

RECORDED WEBINAR: Medical Device Use Error – Root Cause Analysis

About this webinar: In this 60+ minute webinar, Michael Wiklund, Andrea Dwyer and Erin Davis, senior members of the UL Human Factors Engineering (HFE) practice described the regulatory and commercial imperative to identify the most likely root causes of medical device use errors. In this recording, they reflect on the harm that arises from use… read more