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
The latest industry news and insights from our global team. View All
The regulator intends to streamline regulatory submissions with the Regulatory Enrolment Program, using an online...
FDA recognizes the constraints that COVID-19 has placed on in-person testing, but emphasized the importance...
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
We offer biocompatibility, shelf-life, and other non-clinical tests to ensure your device meets regulatory expectations.
Let us help identify and perform all required product testing and validation needed to support your registration dossier in markets worldwide.