Human Factors Research & Design Publications
Gain deep insights into Human Factors Engineering (HFE) and its applications to medical device design by exploring these publications.
The Last Quarter of 2024 in MedTech: It Has Been a Busy Year
Medical device manufacturers who want to stay up to date on the year’s global regulatory developments will appreciate our quarterly regulatory insights.
New Australian Procedure for Recalls, Product Alerts and Product Corrections
The medical device regulator in Australia, the Therapeutic Goods Administration (TGA), announced a preview of a new guidance resource for therapeutic goods corrective actions.
MHRA Finalizes Legislation on Post-Market Surveillance Requirements
The UK medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) finalized the Post-Market Surveillance statutory instrument (PMS SI) in December 2024. Medical device manufacturers doing business in the UK will want to familiarize themselves with this new regulatory requirement to remain compliant and maintain market access.
Brazil’s Medical Device Regulator ANVISA Announces Clinical Investigation Database
As the end of the calendar year approaches, Brazil’s National Health Surveillance Agency (ANVISA) has released its database on clinical investigations.
Tess Forton
Health Canada: Clinical Information on Medical Devices Now Publicly Available
The medical device regulator in Canada, Health Canada (HC), has now made the clinical information provided in support of an application public and it can be accessed via HC’s portal.
2023 South Korea Regulatory Overview
In this webinar, our Emergo by UL subject matter expert outlines the latest updates on medical device regulatory requirements in South Korea.
MHRA Publishes Revised Roadmap of Future Regulatory Framework for Medical Devices
The UK regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), published a revised roadmap outlining the intended timelines for delivering a future regulatory framework for medical devices.
U.S. FDA Medical Device Predicate Selection for 510(k) Submissions
Learn more about the strategies for tackling challenges and boosting submission success for FDA 510(k) predicate selection.