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A Medical Device is an instrument, apparatus, implant, in vitro reagent, or similar or related article that is used to diagnose, prevent, or treat disease or other conditions. A device cannot provide treatment through chemical action. In both the U.S. and Canada, distinct sets of statutory and regulatory provisions apply to medical device research. These provisions place specific requirements on an IRB/REB, including a core determination: whether the device presents a “non-significant risk.” com

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Chiltern International Ltd

Dalmia

MPI Research Inc

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Quorum Review, Inc.

Reliance Clinical Testing Services, Inc

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Quorum understands the complexities of device research. Our boards have extensive experience with devices, our regulatory team can help determine the appropriate classifications for your product, and our support staff can guide you through the particulars of reviewing device research.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Medical Devices

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Quorum has extensive experience with combination products. Our boards and regulatory teams understand the intricacies of combination product research. We can help determine the correct way to manage your study, and we will apply the proper standards for your product.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Medical Devices

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We have an exceptional depth of knowledge in cardiovascular, ophthalmology, oncology, orthopedic, respiratory and women’s health applications of medical devices. Over the last three decades, our medical device study team has successfully managed hundreds of studies for all classes of medical

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Medical Devices

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The medical device expertise available at MPI Research offers pharmaceutical and biotechnology companies leading-edge experience, efficiency, and precision.

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Pharma Service: Clinical Trials

Category: Compliance, Regulatory & Consulting

Sub Category: Medical Devices