MCRA’s leading experts are specialized in achieving success with 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 Wound Care Regulatory Expert
Wound Care & Dermatology 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 spine devices.
MCRA is a world-class provider of regulatory strategy and advice for dermatology, wound care, and traumatic injury devices, including:
• Adhesion prevention
• Allografts
• Barrier devices
• Combination devices
• Dermal fillers
• Dressings
• Homeostatic devices
• Laser devices
• Prosthetic mesh
• Safety syringes
• Scaffolding devices
• Skin grafts
• Suture delivery
• Sutures
• Tissue glues
• Vac systems
• Wound adhesives
US Regulatory Services
MCRA has extensive experience with Class I, II, and III wound care, dermatologic, and traumatic injury indications, successfully navigating a varied set of regulatory pathways.
Our comprehensive ancillary 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