Quality assurance
At Aprikos Medical, every product is developed and manufactured to meet internationally recognized safety and quality standards. Our approach ensures proven compliance, complete, audit-ready documentation, and reduced regulatory and operational risk for those sourcing our devices.
Certificates
All Aprikos Medical products are CE-marked, MDR-certified, and produced under an ISO 13485 quality management system.
- ISO 13485 sets the requirements for a quality management system specific to medical devices.
- MDR 2017/745 is the European regulation for medical devices, involving independent audits, technical documentation, and strict safety testing.
- CE marking confirms that a product meets EU health, safety, and performance requirements, enabling acceptance in European and many global markets.
Quality
Our products are designed and handcrafted by experienced professionals and pass multiple in-process and final inspections before shipment. Our processes align with international standards and are accredited by notified bodies and relevant authorities, ensuring full compliance and traceability.
Rigorous quality control processes ensure consistent performance and reliability across our entire portfolio.
