The healthcare industry is changing and we have the breadth of expertise to help you evolve with it. View All
We have deep expertise with a range of product types, including combination and borderline products.
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.
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More medical device and SaMD manufacturing units now subject to BGMP certification rules
Four new guidance documents from European regulators as IVDR comes into effect
Resources and tools tailored to medical device professionals. View All
Europe's Medical Devices Regulation (MDR) goes into effect in May 2020, and we want you to be prepared. Meet our MDR team and get free educational resources on the MDR.
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Our global consulting team works from 20+ offices on six continents. View All
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Our team of experts has decades of experience in providing guidance on clinical evidence collection requirements, designing respective activities, and conducting medical device clinical studies to European requirements.
Regulatory compliance doesn’t end when your device goes to market. We design compliance solutions informed by a life-cycle approach to device safety and effectiveness.
Put a safer, more competitive device in the hands of patients and healthcare providers. Our human factors experts have deep expertise in medical device design.
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