Quality & Certifications
We are committed to maintaining the highest global standards.
ISO 13485:2016
This certificate confirms that Elevenclock Healthcare Private Limited, Ahmedabad, India, has been independently assessed and certified by Quality Research Organization (QRO) as compliant with ISO 13485:2016 – Quality Management System for Medical Devices. The certification covers the manufacture and global supply of premium-quality dialysis consumables and surgical disposable products, including bicarbonate powders, fistula needles, IV sets, urine collection bags, and related tubing products. Issued on 9 December 2025, the certificate is subject to annual surveillance audits and is valid until 8 December 2028, demonstrating the organization’s commitment to regulatory compliance, product safety, and consistent quality in medical device manufacturing.
ISO 9001:2015
This certificate confirms that Elevenclock Healthcare Private Limited, Ahmedabad, India, has been independently assessed and certified by Quality Research Organization (QRO) as compliant with ISO 9001:2015 Quality Management System requirements. The certification covers the manufacture and global supply of premium-quality dialysis consumables and surgical disposable products, including dialysis concentrates, bicarbonate powders, fistula needles, IV sets, urine collection bags, and blood tubing sets. The certificate was issued on 9 December 2025, is subject to annual surveillance audits, and remains valid until 8 December 2028, demonstrating the organization’s commitment to consistent quality, customer satisfaction, and continual improvement.
