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


Contact a Digital health & Imaging Regulatory Expert