OUR HISTORY, OUR PARTNERS AND COMMITMENT TO QUALITY

Keeping pace with the innovations in the medical regenerative space that directly compliment advancement in spinal technologies, Alliance Spine has partnered with leading surgeons, state of the art manufacturers of human tissue and allografts, and our own proprietary innovations to provide single source quality solutions in the area of orthopedics and regenerative therapies.

Quality is the cornerstone of our commitment to achieve our goals to be the turn-key, “go-to” for our surgeons to achieve consistent favorable outcomes for patients.

QUALITY STATEMENT AND REGULATORY COMPLIANCE

At Alliance Spine, we are committed to complying with regulations and to meeting customer needs. We are "Inspiring Solutions through Innovation" by striving for continual improvement in our process approach.

We do this by maintaining the effectiveness of the Quality management system, periodically reviewing our objectives and instilling risk management principles throughout the product development lifecycle. We operate within the framework of all applicable regulatory requirements.

Alliance Spine is registered with the FDA and our Quality Management System is ISO 13485 certified. By adopting the ISO 13485 standards, we align our commitment to design a quality management system that establishes and maintains the effectiveness of our processes. It ensures the consistent design, development, production, and delivery of medical devices that are safe for their intended purpose. Our implants interbody systems and regenerative medicine solutions meet or exceed the FDA requirements for manufacturers of safe and effective medical devices. Our Biologics are held to the highest quality and regulatory standards, including but not limited to stringent tissue donor screening, recovery, storage and shipping guidelines are followed to best preserve the grafts for their intended functions.

Our top tier allografts meet and exceed the exacting FDA Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P`s) and American Association of Tissue Banks (AATB) standards.

AmnioStrip - Model MKT-701 - Versatile Placental Tissue - Brochure