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

Contact a Wound Care Regulatory Expert