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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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We understand how drug, device, and biologic requirements overlap in the US, Europe, and beyond. We’ll help you define where your product stands in the regulatory landscape.
Our Contract Research Organization (CRO) conducts clinical studies that deliver high-quality clinical data to support pre- and post-market requirements in Europe.
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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