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
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Does your company need to dedicate time and money to human factors engineering (HFE) and/or...
Permanent exemptions from 510(k) requirements proposed for several devices as FDA focuses on COVID-19 public...
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 experienced team of consultants is skilled at identifying and reducing risk in all types of devices and processes.
Leverage our expertise while maintaining a lean, agile business. We can manage all your regulatory and quality operations.
Put a safer, more effective, more competitive device in the hands of patients and healthcare providers. Our human factors experts have deep expertise in medical device design.
The latest industry insights from our global team.