Quality Management Systems (QMS)

Translating complex quality and regulatory requirements into structured, modular management systems. Integrating ISO 13485, ISO 9001, and MDR/IVDR into unified frameworks.

We design quality management systems that integrate ISO 13485, ISO 9001, and MDR/IVDR into unified frameworks. Our approach transforms regulatory requirements into structured, modular systems that scale with your organization.

Our Approach

We apply software engineering principles to quality management — modular design, version control, automation, and data-driven improvement.

Standards & Frameworks

ISO 13485 - Medical device quality management
ISO 9001 - Quality management systems
MDR/IVDR - Medical device and in-vitro diagnostic regulations
Custom frameworks tailored to your industry

Digital-First Design

Every framework we design is built for digital execution. Cloud-based, traceable, scalable, and ready for AI integration.

Interested in QMS Services?

Learn more about how we can help transform your quality management system.