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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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Ordinance No. 384/2020 allows for alternatives to on-site inspections, removes issuance data requirements for test...
FDA rolls out evolving regulatory approach for AI/ML-based software as a medical device (SaMD)
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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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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.
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.