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Advancing Medical Excellence in Saudi Arabia: ENAYAH Achieves MDR Certification from SGS

May 03, 2024

On February 20, 2024, Arabian Medical Products Manufacturing Company (ENAYAH), celebrated a landmark achievement at its headquarters in Riyadh, Saudi Arabia. Commemorating their successful attainment of the Medical Device Regulation (MDR) Certification by SGS, marking a significant milestone in their journey towards excellence in healthcare product manufacturing in KSA.

This certification not only highlighted their commitment to superior product quality and patient safety but also reinforced the ongoing and productive partnership between ENAYAH and SGS, which has been instrumental in achieving this certification.

About Arabian Medical Products Manufacturing Company (ENAYAH)

Founded in 1991 in Riyadh, Saudi Arabia, ENAYAH has established itself as a key player in the healthcare sector. The company produces a wide range of single-use healthcare products including surgical gowns, packs, components, and protective apparel.

Their facility is equipped with the latest manufacturing technologies and includes an in-house sterilization unit. ENAYAH is committed to delivering products that meet diverse operational requirements and ensure patient safety.

Advancing Medical Excellence in Saudi Arabia ENAYAH v4

The Significance of MDR Certification

The MDR Certification, recognized globally, sets a new standard in medical device excellence and safety. It is designed to ensure comprehensive risk management and enhance product quality across all stages of the manufacturing process.

For ENAYAH, obtaining this certification underscores their capability to comply with stringent regulatory requirements and reinforces their commitment to providing safe, high-quality medical products.

Benefits of MDR Certification for ENAYAH

For ENAYAH, the MDR certification offers numerous benefits including:

  • Strengthened global market presence by meeting international safety standards.
  • Enhanced customer trust through demonstrated commitment to quality and safety.
  • Improved operational efficiency by identifying and mitigating potential compliance risks.
  • Increased competitive advantage in the healthcare industry.

SGS Medical Devices Regulatory Compliance Solutions in Saudi Arabia

Powered by our active presence and local expertise in KSA, SGS offers a comprehensive range of certification and training solutions tailored for the medical devices industry, including ISO 13485 and MDR certification.

Our training programs, available both remotely and in-class, cover essential topics such as Medical Device Regulation and Quality Management Systems, equipping professionals with the expertise needed to excel in the global healthcare market.

The MDR certification is a testament to our unwavering dedication to medical product safety and quality. The certification audit by SGS helped us further improve our quality system.

Eng. Ali H. Alnufaie, General Manager, ENAYAH

Eng. Ali H. Alnufaie, General Manager of ENAYAH
We applaud ENAYAH for achieving MDR certification, a clear indication of their commitment to maintaining the highest safety and quality standards.

Syed Atheeq, Lead Auditor and Product Manager for Medical Devices, SGS Saudi Arabia

Syed Atheeq Lead Auditor and Product Manager for Medical Devices

About SGS

We are SGS – the world’s leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories around the world.

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