Results 39 found
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

October 19th, 2016
Webinar: Impact of the New FDA Guidance on 3D Printed Medical Devices

The recording of the recent UL AM and UL Health Services webinar, Impact of the New FDA Guidance on 3D Printed Medical Devices, is now available. The US FDA recently released a draft guidance document for medical device manufacturers working with additive manufacturing (AM). According to FDA, the draft guidance is meant to provide manufacturers… read more

September 19th, 2016
Register Now: Webinar Featuring the New FDA Guidance and 3D Printed Medical Devices

The US FDA recently released a new draft guidance for medical device manufacturers working with additive manufacturing (AM). According to FDA, the draft guidance is meant to provide manufacturers with the agency’s initial thinking about the technical considerations for manufacturing 3D printed devices, as well as its thoughts on characterizing and validating such devices. On… read more

June 1st, 2016
More time to wait until the EU MDR and IVDR are ready

The European Council has reached a political agreement on the proposed/draft Medical Devices and IVD Regulations. The press release, issued May 25th, 2016 marks the end of the wait of the question of when the restructuring that began in 2012 would be put into place. However, although agreement has been met, there are still some… read more

May 6th, 2016
UL continues to Lead in the Issuing of IECEE CB Certificates in MED and MEAS Categories

We are excited to announce that in 2015, UL remained the top global issuer of IECEE CB Scheme certificates for the MED and MEAS categories. As an IECEE National Certification Body (NCB) under the CB Scheme, UL is certified to conduct testing to IEC requirements for most IEC 60601 and IEC 61010 collateral and particular… read more

March 31st, 2016
Medical Device Cybersecurity

Medical Device Cybersecurity Assurance Program and FIPS Testing More and more, medical devices are being connected to IT Networks so that healthcare providers can monitor these devices remotely, automatically record data in electronic format, and more easily connect to electronic health payment systems.  Software applications that run on cell phones and wearable devices such as… read more

March 22nd, 2016
US FDA Medical & Combination Product Regulatory Submissions: Human Factors – FDA’s New and Renewed Expectations About this Webinar Now Available to View Online

In this pre-recorded webinar, UL HFE experts discussed the FDA’s new and renewed expectations regarding the application of Human Factors Engineering (HFE) to medical devices that call upon users to perform critical tasks.  The discussion centered around our experts’ experience helping customers generate appropriate human factors data to support pre-market submissions. The recording includes responses… read more

March 21st, 2016
UL Experts Present at AAMI 2016

Saturday, June 4th: 3:30 p.m.- 4:15 p.m. Informing FDA Regulatory Policy for Cybersecurity through Software Testing In recent years, the FDA has been challenged with keeping pace with the rapidly changing cybersecurity threat landscape in the medical device sector.  As awareness of these issues grows, the community of healthcare stakeholders would hope to see regulatory… read more

March 21st, 2016
UL’s Anura Fernando Selected for Healthcare Industry Cybersecurity Task Force by Health & Human Services

Anura Fernando, Principle Engineer, UL LLC selected as a member of the Healthcare Industry Cybersecurity Task Force by HHS. For more information on the Healthcare Industry Cybersecurity Task Force and its mission, please visit  http://www.hhs.gov/blog/2016/03/16/healthcare-industry-cybersecurity-task-force.html.

March 9th, 2016
UL Provides Medical Device Manufacturers Alternative to Traditional CFDA Testing

Mounds View, Minn., March 9, 2016 – UL, a global safety science organization, today announced the launch of its new China Food and Drug Administration (CFDA) testing program for medical device manufacturers. This program allows medical device manufacturers outside of China the option to participate in and complete the required series of tests for CFDA… read more