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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Currently Brexit is planned on 29 March 2019, but it is not clear how this...
EMERGO BY UL SUMMARY OF KEY POINTS: FDA has issued final guidance on medical devices...
Resources and tools tailored to medical device professionals. View All
Selling a medical device in Japan requires manufacturers to comply with the Japanese Pharmaceutical and Medical Device Act (PMD Act) and its corresponding registration process...
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Leverage approvals in key markets to expand globally. We’ll design a regulatory and quality strategy that takes your product to established and emerging markets worldwide.
Leverage our expertise while maintaining a lean, agile business. We can manage all your regulatory and quality operations.
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.
The latest industry insights from our global team.
