All products are CE marked and manufactured under ISO 13485. Our operations fully comply with MDR 2017/745, covering product safety, clinical performance, and post-market oversight. Our MDR conformity process included an audit by a notified body, reviewing both our quality system and technical documentation. CERTIFIED AND COMPLIANT
For distributors, hospitals, and procurement professionals, this means:
Complete technical documentation to support tenders, registrations, and approvals. Reduced administrative delays during audits and evaluations. Lower supplier risk, with clearly defined accountability. Assurance that products are manufactured and monitored with patient safety at the core.
Compliance for us is not just a legal requirement. It is a safeguard for healthcare providers and a quality signal for those seeking reliable long-term partners.
BUILT FOR RANGE, CONTINUITY, AND VALUE
Aprikos Medical oers a broad portfolio, competitive pricing, and dependable supply. This combination helps partners compete eectively without compromising on quality or compliance.
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