Contact a Wound Care Quality Assurance Expert

Wound Care & Dermatology Experience

MCRA offers unparalleled support to develop quality systems compliant with ISO 13485, FDA Quality System Regulation and other global QMS requirements to support development of wound care and dermatology devices. Our interdisciplinary team will help you assure ongoing compliance with design control procedures for wound care devices all the way from device conception through release to market.

Some key therapy areas of expertise 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

Quality Assurance Services

Our team offers setup of procedures for document control, R&D, risk management, software development, supplier evaluation, and control of measurement equipment, amongst others.

Our comprehensive quality assurance and manufacturing services include: 

•    Quality System Development

•    Gap assessments

•    Manufacturing and materials

•    Mobile apps and software

•    Mock inspections

•    Perform internal quality system audits

•    QA support

•    Technical documentation and technical submissions 

Contact a Wound Care Quality Assurance Expert