MCRA’s leading experts are specialized in achieving success with international regulatory bodies. Our team has industry leading experience with global regulatory strategy and deep understanding of the device lifecycle. We assist 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 regulatory agencies in demonstrating the science, safety, and efficacy of their technologies.
Contact a Wound Care Regulatory Expert
Wound Care & Dermatology Regulatory Experience
MCRA’s team of experts has successfully navigated hundreds of international regulatory submissions. Our expertise extends to European, Australian, and Canadian markets, successfully remediating Technical Files and Clinical Evaluation Reports (EU CER) for compliance with MEDDEV 2.7.1. Rev. 4 for hundreds of medical devices across the industry.
Our services for dermatology, wound care, and traumatic injury devices include:
• 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
International 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:
• Agency/Notified Body interaction
• Clinical testing plan
• Design dossier and technical file gap assessment
• Device classification
• Device listing
• Due diligence services
• Establishment registration
• European Technical Files and Clinical Evaluation Reports (EU CER) compliant to the EU MDR
• Gap Assessment of Key Chemical/Material Restrictions (such as those found in REACH, RoHS, BPR & CLP)
• Global regulatory strategy
• Import/export
• Labeling
• Medical device reporting
• Mock audits
• Notified body submission/Response
• Post-market surveillance
• Pre-clinical testing plan
• Quality system gap assessment
• Regulatory file letters
• Regulatory landscape assessment
• Training (EU MDR)