Medical Devices

The healthcare services in any nation are dependent upon the efficiency to provide treatment in a timely manner. Apart from infrastructure and skilled resources, the equipment and the devices that are used for the treatment are needed to go through various levels of quality and safety scrutiny. One of the major cities of middle east as well as the world, Dubai has enough reasons to boast about its medical infrastructure. However, one must note that the medical devices that are both external as well as implantable in nature are required to prove their safety and quality from time to time. In that regard, for all those organizations that manufacture or supply the medical devices, gaining ISO certifications is extremely beneficial.

The organizations that manufacture medical devices can go for ISO 9001, ISO 13485, ISO 14001, and ISO 14971 to ensure their customers about the quality of their products and processes as well as to comply with the related legislations in the country.

Let us understand about these standards in brief:

ISO 9001 Standard:

ISO 9001 standard helps in implementing the quality management systems (QMS) in your organization. This ensures the overall quality of your products and processes.

ISO 14001 Standard:

This standard provides a framework for the establishment of Environmental Management Systems (EMS) that helps in improving the interaction of your organization with the environment.

ISO 13485 Standard:

This is a quality management standard that is specific for the medical devices. It ensures the quality, safety, and efficacy of your products. This standard also acts as a basic requirement in many countries for the approval of the sale of medical devices.

ISO 14971 Standard:

This standard helps in the identification of potential risk associated with your medical devices and establishment the necessary controls to prevent or mitigate them.

It must be noted that the International Organization for Standardization does not certify, it just publishes the ISO standards. An external body performs the certification. SIS Certification is one such body which has a reputation for being one of the best in the world. Our vast pool of auditors is recognized for their expertise in comprehensively auditing the compliance of your management systems against the required standards and awarding you with the certifications at the end. The smoothness in the process, our integrity, and our commitment to deadlines make us stand apart from other certification bodies.

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