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ISO 13485 (Medical Devices)

ISO 13485:2016 specifies requirements for a quality management system that can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development, and provision of related services. The primary purpose of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems.

Benefits: ISO 13485 can help organizations involved in any part of a medical device’s life cycle: Demonstrate compliance with regulatory and legal requirements ,ensure the establishment of QMS practices that consistently yield safe and effective medical devices ,manage risk effectively ,improve processes and efficiencies as necessary and gain a competitive advantage.

The ISO certifications are issued by various Certification Bodies accredited by accreditation boards like DAC (Dubai Accreditation Centre), IAS (International Accreditation Service) etc.

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