MCRA’s leading experts are specialized in achieving success with the US FDA. Our team has industry leading experience with global regulatory strategy and deep understanding of the device lifecycle assisting through the developmental process, including conception and design considerations, pre-clinical and clinical testing, regulatory application through clearance/approval, and commercialization, providing MCRA's clients with the best representation to the US FDA in demonstrating the science, safety, and efficacy of their technologies.
Contact a Digital Health & Imaging Regulatory Expert
Digital Health & Imaging Experience
MCRA’s team of experts has successfully navigated hundreds of US FDA submissions ranging from 510(k)s to PMAs involving advanced first-in-class diagnostic devices.
MCRA is a world-class provider of regulatory strategy and advice for robotic, imaging and digital health devices, including:
• Fluoroscopy devices
• Guidance systems
• Video systems
• Robotic surgery systems
• Software
• Applications
US Regulatory Services
MCRA has industry leading specialization in the full spectrum of robotic, imaging and digital health medical devices, with strong regulatory and scientific leadership offering deep expertise.
Our comprehensive regulatory services include:
• Global and US regulatory strategy
• Regulatory landscape assessment
• Gap analysis
• Investigational Device Exemption (IDE)
• De Novo
• 510(k)
• Premarket Approval (PMA)
• FDA appeals
• FDA training
• FDA warning letters and 483 observations
• Pre-clinical testing plan
• Clinical testing plan
• Due diligence services
• Agency interaction
• Device classification
• Import/export
• Labeling
• FDA meeting strategy
• Real-time reviews
• Device listing
• Establishment registration
• Regulatory file letters
• Medical device reporting
• IDE Reporting