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 General Surgery & Plastic Surgery Regulatory Expert
General Surgery & Plastic Surgery 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 surgical devices.
MCRA is a world-class provider of regulatory strategy and advice for general surgery and plastic surgery devices, including:
• Aspirators
• Bandages
• Barrier devices
• Biomaterials
• Breast implants
• Compression garments
• Dermal fillers
• Dressings
• Garments
• Glues
• Laser devices
• Light therapy devices
• POC diagnostic tests
• Saline solutions
• Scaffolding
• Stapes
• Surgical instruments
• Surgical mesh
• Surgical towers
• Sutures
• Syringes
US Regulatory
MCRA has industry leading specialization in the full spectrum of general surgery and plastic surgery 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 General Surgery & Plastic Surgery Regulatory Expert