ISO 13485 Certification in Oman | ISO 13485 Certification body - Oman

 The ISO 13485:2016 quality management system (QMS) standard for medical devices was introduced in 1st March 2016, with the Accreditation enabling the transition of certified organizations from previous versions within three years. IAS is an established ISO 13485 certification body in Oman, we can assist you in your journey towards local and international compliance. ISO 13485 certification for medical devices is an internationally recognized quality standard which affirms the requirements of the Quality Management System (QMS) for the design and manufacture of Medical Devices anywhere in the world.

ISO 13485 certification for Medical Equipments establishes subtle, yet characteristic changes demanding in-depth documentation on the work environment, risk assessment, design authority and regulatory specification. ISO 13485 certification is applicable to both manufacturers of medical devices and organizations that support medical device manufacturers. It supports the manufacturer’s responsibility for guaranteeing medical devices invariably meet customer requirements and applicable regulatory specifications.

ISO 13485:2016 Certification is conceived in a detail to respond to current quality management system practices, inclusive of alters in technology and regulatory requirements and expectations.

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