Regulatory

Compliance

At Accuratus, we place the highest value on safety, reliability, and legally compliant products. Our processes combine Swiss precision with structured quality and compliance standards, ensuring that medical users can trust our products at all times.

Origin

All Accuratus/ Subtilis instruments are developed and manufactured in Switzerland. This allows us to control production closely, ensure maximum precision, and utilize short decision-making paths. Accuratus and the Subtilis brand stand for precise manufacturing, durability, and transparency.

UDI Code & Product Labeling

Each instrument is provided with a UDI code (Unique Device Identification) to ensure traceability, tracking, and safety monitoring:

  • 2D matrix code directly on the instruments for easy identification and tracking
  • 2D matrix code and barcode on the label for logistics, storage, and documentation.

This ensures that every product is uniquely identifiable and that all regulatory requirements for labeling are met.

Certifications & Standards

Our products meet international standards and legal requirements:

  • ISO 13485: Certified quality management system for medical devices, covering all processes from development and manufacturing to service.

  • CE Marking: Compliance with European directives for medical devices.

  • Medical Device Regulation (MDR): Implementation of the Medical Device Regulation (EU) for secure product approval in Europe.

  • Other Standards: National and international standards relevant to surgical instruments and implants are strictly adhered to.

Regulatory Processes

Our regulatory workflows are firmly integrated into the development and manufacturing process:

  • Documentation: Complete recording of all testing and release processes.

  • Audits & Inspections: Regular internal and external reviews to ensure compliance.

  • Post-Market Surveillance: Continuous monitoring after market launch to maintain all safety and quality requirements.

  • Regular Training: Employees receive continuous training on standards, regulations, and new legal requirements.