Our Therapeutic Expertise
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.
MCRA's Cardiovascular team has decades of combined cardiovascular experience and direct oversight from a former FDA Branch Chief in cardiovascular devices.
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.
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.
Biologics & Combination Devices
MCRA's Biologics team is well-positioned to help clients overcome the scientific and manufacturing complexities of biologic product development.
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.
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.
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.
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.
MCRA's Dental team has decades of combined experience and direct oversight from multiple former FDA personnel from the dental field.
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.
Anesthesia and Critical Care Devices
MCRA's Anesthesia team has decades of combined anesthesia and critical care experience and direct oversight from multiple former FDA personnel in anesthesia, respiratory, sleep and critical care devices.
MCRA's Biocompatibility team has extensive experience successfully navigating regulatory biocompatibility expectations for complex medical devices.