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)

Contact a Wound Care Regulatory Expert