We are leaders in designing and remediating quality management systems under strict and changing standards. MCRA ensures compliance with ISO 13485, FDA Quality System Regulation, and other global QMS requirements, with special emphasis in establishing procedures for regulatory compliance tailored to your product line and target markets.
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