Our Therapeutic Expertise
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Orthopedics & Orthopaedic Devices/Biologics
Led by the former Branch Chief of the US FDA's Orthopedic Devices Branch, MCRA's Orthopedics team is skillfully positioned to take on any orthopedic projects.
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Cardiovascular Devices/Biologics
MCRA's Cardiovascular team has decades of combined cardiovascular experience and direct oversight from a former FDA Branch Chief in cardiovascular devices.
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Spine & Spinal Devices/Biologics
MCRA's Spine team has extensive expertise in the medical device industry, which has been strengthened through projects with over 500 clients in the past 20 years.
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Wound Care & Dermatology Devices/Biologics
MCRA's proprietary system of combining our integrated services in clinical trials lends itself very well to the wound care technology lifecycle.
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Biologics & Combination Devices
MCRA's Biologics team is well-positioned to help clients overcome the scientific and manufacturing complexities of biologic product development.
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Neurology & Neurosurgical Devices/Biologics
MCRA's Neurology & Neurosurgical Devices team is at the core of our 150+ years of experience. We advise leading neurosurgical healthcare companies across a wide range of clinical issues.
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Imaging & Robotics
MCRA's Imaging and Robotics team has industry leading experience with advanced first-in-class medical devices, including the most recent AI/ML, robotic, diagnostic and image-assisted surgical devices.
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Digital Health
MCRA's Digital Health team offers top quality consultations and representation for companies navigating the complex route to market for Digital Health and AI/ML products.
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General & Plastic Surgery
MCRA's General & Plastic Surgery team has decades of experience with the complete risk-spectrum of surgical devices, ranging from low-risk devices to complex first-in-class, high-risk devices.
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Dental Devices
MCRA's Dental team has decades of combined experience and direct oversight from multiple former FDA personnel from the dental field.
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In-Vitro Diagnostic Devices
MCRA's IVD team has decades of combined experience and direct oversight from multiple former FDA and Notified Body personnel from the IVD field.
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Anesthesia, Respiratory, Sleep, & ENT Devices
MCRA's Anesthesia team has decades of combined anesthesia, respiratory, sleep, & ENT experience and direct oversight from multiple former FDA personnel in anesthesia, respiratory, sleep and critical care devices.
Learn More About Our Anesthesia, Respiratory, Sleep & ENT Expertise
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Biocompatibility Services
MCRA's Biocompatibility team has extensive experience successfully navigating regulatory biocompatibility expectations for complex medical devices.
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Cell and Gene Therapy
MCRA’s Cell and Gene Therapy Team provides expert regulatory strategy and clinical development consulting support relating to advanced therapies through development to commercialization