Contact a Spine Quality Assurance Expert

Spine Quality Assurance 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 spine devices. Our interdisciplinary team will help you assure ongoing compliance with design control procedures for spine devices all the way from device conception through release to market.

Some key spine therapy areas of expertise include:

•    3D printed devices

•    Annulus repair

•    Atlanto-cervico-thoracic fixation systems

•    Bone void fillers

•    Cervical interbody cages

•    Combination devices

•    Disc nucleus replacement

•    Dura/vertebrae anti-adhesion

•    Hydrocephalic shunt devices

•    Instrument navigation systems

•    Laminoplasty plates

•    Lumbar interbody cages

•    Pain relief

•    Pedicle screw systems

•    Reconstruction of intervertebral disc

•    SI-joint screws

•    Spinal fusion

•    Spine surgery

•    Total disc replacement

•    Vertebral augmentation

•    Vertebral body replacements

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 Spine Quality Assurance Expert