Contact a Biologics Quality Assurance Expert

Biologics 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 robotic, imaging and digital health devices. Our interdisciplinary team will help you assure ongoing compliance with design control procedures for your devices all the way from device conception through release to market. Some key therapy areas of expertise include:

•    Allografts and demineralized bone matrix products

•    Autografts

•    Bone cement

•    Bone Morphogenic Proteins (BMP)

•    Bone substitutes

•    Cartilage repair systems

•    Growth Factors

•    Hyaluronic acid

•    Orthobiologics

•    Platelet concentration

•    Resorbable fixation devices

•    Scaffold devices

•    Soft tissue and tendon grafts

•    Stem cells

•    Surgical glues

•    Surgical sealants

•    Synthetic cartilage

•    Xenografts

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 Biologics Quality Assurance Expert