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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...
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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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Our Contract Research Organization (CRO) conducts clinical studies that deliver high-quality clinical data to support pre- and post-market requirements in Europe.
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.
The latest industry insights from our global team.
