The healthcare industry is changing and we have the breadth of expertise to help you evolve with it.
Comprehensive service offerings at every point in the product life cycle.
A platform of digital products to improve, simplify and automate RA/QA activities
Emergo by UL's new human factors tool - provides training, tools, and resources.
Our software tools offer digital regulatory monitoring for medical device compliance and access to human factors engineering tools.
The latest industry news and insights from our global team.
Stay informed with the most read RA/QA medical device newsletter.
TalkingPoints is a round-up of news, insights, and resources about human factors and usability for medical devices, IVDs, combination products, and more.
Information and tools to advance your business.
Learn from our experts through live events.
Our global consulting team works from 20+ offices on six continents.
Japanese medical device regulators have updated program codes and labeling rules.
US regulators lay out recommendations for HFE information to include in medical device registration applications
The US FDA has announced that manufacturers of new COVID-19 tests should now follow traditional premarket pathways.
The US FDA announced that it has launched a pilot program designed to help medical device premarket reviews become more efficient.
The UK’s MHRA invited public comment regarding its proposed fee increases.
The US FDA released a list of guidances it plans to issue over its 2023 fiscal year.
A use-related risk analysis (URRA) is an important cornerstone activity in your human factors engineering (HFE) process that is expected by regulators.
A survey from the European Commission shows that many medical device and in vitro diagnostic (IVD) manufacturers have yet to apply for certification under the Medical Devices Regulation (MDR) or In Vitro Diagnostic Medical Devices Regulation (IVDR).
Health Canada finalized guidance on clinical evidence requirements for medical devices.
Health Canada reminded manufacturers of EHR-based medical devices to obtain a medical device license and/or establishment license.
Malaysia’s MDA published draft guidance that provides a notification process for manufacturers of custom-made medical products when seeking Malaysian market access.
The US FDA has issued draft guidance on select updates for the Breakthrough Devices Program guidance, expanding its scope to devices that will improve accessibility.
The FDA released its 2023 medical device user fees and some have increased sharply since last year.
Taiwan’s MOHW has issued a draft revision of UDI requirements and a draft amendment of the charge standards of administrative fees for medical devices.
The US FDA has revised its guidance document to update the considerations on identifying and responding to deficiencies in premarket submissions.
New laws will enable manufacturers to leverage their FDA registrations for Swiss market access
Electronic indications for use (IFUs) becoming more common for medical products and devices
US FDA issued revised guidance on definitions of device and counterfeit device. FDA also issued a revised MedWatch Form 3500A for adverse event reporting
New and upgraded learning management and training features to support pharmaceutical, medical device and biotechnology companies
New provisions cover products with no intended medical purpose
