Our Certifications
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ISO(13485)
ISO 13485 is an internationally recognized standard for quality management in the medical device industry. It ensures that products are consistently designed, developed, and delivered in compliance with strict regulatory and safety requirements.
FDA Registration
FDA registration shows that the manufacturing establishment is registered with the U.S. Food and Drug Administration and meets applicable requirements for medical device listing and market access. It supports regulatory transparency and helps ensure that products are manufactured, documented, and distributed in alignment with U.S. medical device compliance expectations.
DRAP – Drug Regulatory Authority Pakistan
DRAP registration confirms that the manufacturer or product is registered with the Drug Regulatory Authority of Pakistan, supporting compliance with national healthcare and medical device regulations. It helps ensure that products are manufactured, documented, and distributed in accordance with Pakistan’s regulatory standards for quality, safety, and market authorization.
Quality Policy – Medzah OEM Pvt. Ltd.
Medzah OEM is committed to delivering high-quality medical products that meet customer expectations and comply with applicable regulatory and international standards through continuous improvement and an effective Quality Management System.