Therapy Specialization

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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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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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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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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MCRA's Biologics team is well-positioned to help clients overcome the scientific and manufacturing complexities of biologic product development. 

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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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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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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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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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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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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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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.

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MCRA's Biocompatibility team has extensive experience successfully navigating regulatory biocompatibility expectations for complex medical devices.

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MCRA’s Cell and Gene Therapy Team provides expert regulatory strategy and clinical development consulting support relating to advanced therapies through development to commercialization

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