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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.” complexities of device research. With extensive experience with devices, regulatory team can help determine the appropriate classifications for products, and particulars of reviewing device research. Medical device evaluation involves evaluating the preclinical efficacy and safety of Sponsors’ medical devices, biopharmaceuticals, or combination products.Companies offer global reach for medical device development, providing the most advanced methods for effective evaluation, verification, and validation of medical device design. Different Medical device models may comprise Cardiac and peripheral models, Orthopaedic models, Central Nervous System (CNS) and peripheral models, Dental, gastroenterological, drug delivery, urologic, and wound healing etc. The biocompatibility of medical devices evaluation models may comprise Guinea pig sensitization/maximization, Skin irritation/intracutaneous reactivity, Acute systemic toxicity, Hemocompatibility, Biodegradation evaluations, Subcutaneous or intramuscular implantation, Subchronic and chronic toxicity, Developmental and reproductive testing, Carcinogenicity. Companies provide exceptional depth of knowledge, Product Lifecycle Expertise, risk-based monitoring, site engagement, patient recruitment and retention, strategic development, strategic service provision, global reach, in cardiovascular, dermatology, ophthalmology, oncology, orthopedic, respiratory, endocrine and metabolic, neuroscience, radiology and nuclear medicine and women’s health applications of medical devices, development of combination device/drug delivery systems and implement the guidelines governing mobile medical technology. Medical Device & Diagnostics teams can help with Protocol development, Site/investigator selection, Clinical studies, Pilot/feasibility, Pivotal, Continued access, Post-market, Registries, Regulatory consulting, Adjunctive reimbursement programs, Safety surveillance/observational programs, Clinical evaluation reports, General and regulatory frameworks of mobile medical applications and regulation standards, Software programming, off-the-shelf software, cybersecurity and risk of mobile platforms, Preclinical and clinical operations: considerations for mobile technology resource requirements, usability and human factor requirements, Data integration, imaging requirements and visual analytics, Economic and reimbursement considerations for mobile technology in a clinical trial. Clinical trial clinical research companies provides full-service pre-market, post-approval and post-market device trial management supporting human trials in all phases, from single-center feasibility trials to large multi-center, randomized controlled trials, with a full range of clinical services. The medical device environment is changing with numerous challenges posed to the medical technology landscape the cost and complexity of analytics to drive innovation, the volume and complexity of guidances from the FDA, EMA, and other global health authorities, and increasingly complex regulatory quality compliance standards. Device clinical trials provide unique challenges eg. trials tend to be smaller than drug trials, endpoints are highly diverse, and many are difficult to blind, randomize, and control. Medical devices include Implantable, Imaging, In vitro diagnostic device (IVD), Analyzers, Capital equipment and disposables, Over-the-counter (OTC) devices, Mobil health apps, Wearables, Delivery devices. Abundant opportunities exist within the medical device industry as well. Connecting devices to the Internet of Things, additive manufacturing, and the increasing feasibility and demand of wearable health technology each offer opportunities for new device innovators, software technology companies, and large scale medical device manufacturers.

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    Chiltern International Ltd

    Dalmia

    MPI Research Inc

    Pharmaceutical Product Development, LLC

    Quorum Review, Inc.

    Reliance Clinical Testing Services, Inc

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    Quorum Review, Inc.

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    Device Studies

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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

    Quorum Review, Inc.

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    Combination Product Studies

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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

    MPI Research Inc

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      Medical Device Evaluation

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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

      Reliance Clinical Testing Services, Inc

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        Pharmaceutical & Medical Device Testing

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        RCTS offers complete clinical testing services for topical drugs and medical devices. Our team has extensive experience in the design and execution of protocols to support the safety and therapeutic benefits of topical drugs and devices across numerous therapeutic areas.

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        Pharma Service: Clinical Trials

        Category: Compliance, Regulatory & Consulting

        Sub Category: Medical Devices

        Chiltern International Ltd

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          UNITED KINGDOM United Kingdom

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          Medical Device & Diagnostics

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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

          Pharmaceutical Product Development, LLC

          • FDA

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          Medical Device Development Industry Expertise

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          Clients can accelerate the process of bringing their new products to market with the experience, resources and global reach of PPD’s medical device development team.

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          Pharma Service: Clinical Trials

          Category: Compliance, Regulatory & Consulting

          Sub Category: Medical Devices

          Dalmia

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            INDIA India

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            Medical Devices

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            Launch your Medical Device in the market with DRDL. We have built the absolute roadmap by keeping in view the FDA, EMA and other necessary regulations. Where, we are keeping a top view on the data monitoring, safety and risk-management.

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            Pharma Service: Clinical Trials

            Category: Compliance, Regulatory & Consulting

            Sub Category: Medical Devices

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