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Quality Management System according to ISO 13485

ISO 13485 is the internationally recognized quality management standard for medical device manufacturers. It ensures that our medical devices consistently meet customer expectations and regulatory requirements throughout the product lifecycle.

  • Emphasizes design controls, risk management, traceability, and supplier oversight
  • Serves as the foundation for EU MDR and global regulatory frameworks
  • Audited annually by an accredited Notified Body

This assures stakeholders of consistent quality, safety, and regulatory conformity across markets.