Quality & Compliance

Commitment to Compliance. Culture of Quality.

At Mediologix Biopharma, quality is engineered into every layer of our operation. We maintain full adherence to regulatory guidelines and ensure all products are manufactured, assembled, and tested in line with global standards.

Our Quality Standards
  • ISO 13485:2016 Certified
  • FDA 21 CFR Part 820 Compliant
  • EU MDR & CE Mark Ready
  • Full CAPA, NCR, and change control systems
  • Periodic internal audits and third-party inspections
  • Training & competency tracking system for all staff
Client Support

We offer audit hosting services and detailed documentation support for our clients during regulatory reviews.