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We have deep expertise with a range of product types, including combination and borderline products.
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A platform of digital products to improve, simplify and automate RA/QA activities
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FDA plans improvements to Emergency Use Authorization (EUA) processes, supply chain evaluations and other COVID-19...
The authority released an announcement and guidance for the voluntary record filing procedure, and the...
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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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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 team of experts has decades of experience in providing guidance on clinical evidence collection requirements, designing respective activities, and conducting medical device clinical studies to European requirements.
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.