Achieve global quality standards in medical device manufacturing with ISO 13485 Certification Services in Muscat offered by Qualitcert, a trusted name in quality and regulatory compliance across Oman and the GCC. ISO 13485:2016 is the internationally recognized standard for Quality Management Systems (QMS) for medical devices, designed to ensure the consistent design, development, production, installation, and delivery of medical devices that meet customer and regulatory requirements.

At Qualitcert, we provide complete ISO 13485 implementation and certification support in Muscat, including gap analysis, risk-based process mapping, QMS documentation, internal audits, employee training, and coordination with accredited certification bodies. Our expert consultants work with manufacturers, suppliers, and distributors in the healthcare sector to build compliant, efficient, and audit-ready systems.