We are leaders in designing and remediating quality management systems under strict and changing standards for medical device companies. 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 Dental Quality Assurance Expert
Dental Experience
MCRA offers unparalleled consulting support to develop quality systems compliant with ISO 13485, FDA Quality System Regulation and other global QMS requirements to support development of dental devices. Our interdisciplinary team will help you assure ongoing compliance with design control procedures for dental devices all the way from device conception through release to market. Some key therapy areas of expertise include:
- Additive Manufactured Dental devices (e.g., customized Implants, Crowns, Plates, Dentures, Restorations etc.)
- Bone Grafts
- Bone Substitutes
- Dental Abutments
- Dental Amalgams
- Dental Cements
- Dental Combination Products
- Dental Imaging Equipment
- Dental Implants
- Dental Membranes
- Dental Plates
- Intraosseous Fixations
- Lasers
- Mandibular Condyle Prostheses
- Maxillofacial Reconstruction Implants
- Orthodontic Appliances
- OTC Denture Cushions
- Total Temporomandibular Joint Prostheses
- Transmandibular Implants
Quality Assurance and Manufacturing 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 consulting 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