Quality Policy Statement

GCMI is committed to developing and manufacturing safe, effective, and high-quality medical devices to ensure patient safety, meet customer needs, and fulfill regulatory requirements. GCMI accomplishes this by:

  • Meeting and exceeding customer needs with our commitment to integrity, responsibility, teamwork, professionalism, and quality
  • Continuous improvement of products, processes, and services
  • Compliance with applicable regulations, requirements, and standards
  • Maintaining an effective quality management system

The quality policy is supported by documented measurable quality objectives and goals, which are established and reviewed during periodic Management Reviews.

Reference: QMS-0001 RO2 §4

Regulatory Compliance

GCMI implements appropriate systems and practices on a corporate and per-project basis.

Good Manufacturing Practices: 21 CFR 210
Quality Systems Regulations: 21 CFR 820, ISO 13485

501(c)(3) Nonprofit

Affiliate of Georgia Institute of Technology/USG

Member of :

Georgia Bio Life Sciences Partnership
Southeastern Medical Device Association