News

Sep 27, 2023

US FDA Announces Permanent Accreditation Scheme for Conformity Assessment Program

The US FDA issued several regulatory updates, including ASCA becoming a permanent program, guidance for participation in the VIP and updates to guidance on the Breakthrough Devices Program and draft guidance on medical devices associated with weight loss.

Man trying an at-home blood pressure device

Sep 21, 2023

Out-of-the-Box Usability Testing for Medical Devices | Emergo by UL

Human factors specialists might opt to conduct an “out of the box” usability test of a medical device, such as for a home-use blood pressure monitor. In any case, it’s a great way to assess the user experience from the very start of product interactions.

Sep 21, 2023

UI Design Trends for Healthcare and Medical Apps

Good user interface (UI) design ensures that users have a valuable and enjoyable experience when interacting with an application. For mobile apps related to healthcare, a UI that prioritizes the user is of utmost importance as these applications are developed with the goal of improving patients’ lives and the level of care they receive.

Sep 21, 2023

Webinar Debrief: Discovery and Design Methods for User-Centered Product Development

On August 24, 2023, our Human Factors (HF) team’s Cory Costantino and Julee Henry delivered a webinar about how to approach early research, discovery and design during new product development efforts to build a strong user-centered foundation.

multiple analysts conducting a usability study

Sep 20, 2023

Conducting Usability Tests with Multiple Analysts | Emergo by UL

Overcome challenges associated with conducting human factors usability tests with multiple analysts by practicing effective notetaking and data collection.

Sep 18, 2023

Details on Declaration Route for Class I Medical Devices in Israel

As Emergo by UL reported in August, the Ministry of Health in Israel, Medical Device Division, AMAR, announced (August 14, 2023) proposed amendments to the medical device regulatory system.

Sep 13, 2023

US FDA Finalizes 2016 HFE Draft Guidance for Combination Products

FDA released new Q&A-style guidance document finalizing 2016 HFE draft guidance for combination products

Sep 5, 2023

UK MHRA Announces Three New Approved Bodies to Certify Medical Devices

On August 29, 2023, the Medicines and Healthcare Products Regulatory Agency (MHRA) announced that they had designated three new UK Approved Bodies, almost doubling the UK’s current capacity to certify medical devices.

Sep 1, 2023

Medical Device and IVD Compliance in Switzerland: Key Deadlines and Reminders

Key medical device and IVD registration and compliance considerations now that Switzerland has "third country" status in relation to the EU

Aug 30, 2023

Brazilian Regulator ANVISA Amends Medical Device Import Law

Brazil’s medical device regulator has amended its import policy to include medical devices with manufacture dates that precede registration dates.

Aug 23, 2023

Amendments Proposed to the Medical Device Regulatory System in Israel

The Medical Device Division, AMAR, of the Ministry of Health in Israel has announced proposed amendments to the medical device regulatory system (August 14, 2023). The changes are intended to reduce the registration and import timelines.

Aug 22, 2023

Comparing Human Factors Engineering (HFE) in Medical and Automotive Product Design

Here we highlight similarities and differences between HFE as it applies to medical and automotive fields.

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US FDA Announces Permanent Accreditation Scheme for Conformity Assessment Program

Out-of-the-Box Usability Testing for Medical Devices | Emergo by UL

UI Design Trends for Healthcare and Medical Apps

Webinar Debrief: Discovery and Design Methods for User-Centered Product Development

Conducting Usability Tests with Multiple Analysts | Emergo by UL

Details on Declaration Route for Class I Medical Devices in Israel

US FDA Finalizes 2016 HFE Draft Guidance for Combination Products

UK MHRA Announces Three New Approved Bodies to Certify Medical Devices

Medical Device and IVD Compliance in Switzerland: Key Deadlines and Reminders

Brazilian Regulator ANVISA Amends Medical Device Import Law

Amendments Proposed to the Medical Device Regulatory System in Israel

Comparing Human Factors Engineering (HFE) in Medical and Automotive Product Design

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