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.