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.
Cardiology & Cardiovascular Devices/Biologics
MCRA Cardio 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 expertise 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 medical device therapy consulting services in clinical trials lends itself very well to the wound care technology lifecycle.
Biologics & Combination Devices
MCRA is well-positioned to help clients overcome the scientific and manufacturing complexities of biologic product development through our medical device therapies expertise.
Neurology & Neurosurgical Devices/Biologics
Neurology & Neurosurgical Devices are at the core of MCRA’s 150+ years of experience as medical devices therapy consultants. We advise leading neurosurgical healthcare companies across a wide range of clinical and regulatory issues.
Imaging & Robotics
Our team has industry leading experience with advanced first-in-class medical devices, including the most recent robotic, diagnostic and image-assisted surgical devices.
MCRA's team offers top quality advice and representation for companies navigating the complex route to market for Digital Health products.
General & Plastic Surgery
We have 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 In-Vitro Diagnostic team has decades of combined experience and direct oversight from multiple former FDA and Notified Body personnel from the global IVD field.
Anesthesia and Critical Care Devices
MCRA Anesthesia has decades of combined anesthesia and critical care experience and direct oversight from multiple former FDA personnel in anesthesia and critical care devices.