Medical Device registration as per ISO 13485: 2016 - Quality Management Systems

The International Organization for Standardization derived the Quality Management Standard for the medical device known as ISO 13485 under the ISO 9000 QMS standard series. The ISO 13485 follows the ISO 9000 process-based model for a regulated medical device manufacturing environment.

The new version of ISO 13485 is ISO 13485:2016 is QMS for a medical device. It also demonstrates the quality of medical and also checks whether it fulfil the customer requirement or not. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). The organization who provide product including the QMS related services also used ISO 13485:2016.

The benefit of ISO 13485 certification:

1.If you are the medical device manufacturers and want to expand locally or operate internationally. ISO 13458 is the solution.

2. ISO 13485 helps to improve overall performance, eliminate uncertainty, and widen market opportunities.  

3.ISO 13485 is the quality management system standard accepted as the basis for CE marking medical devices under European Directives.

ISO 13485:2016 Requirements for Medical Device:

The ISO 13485:2016 requirements are applicable for organizations regardless of their size and regardless of their type except where explicitly stated. The requirements are specified that is it applied to both the product and product-related services supplied by the organization.

"The new ISO 13485:2016" focuses on how companies should manage risk-based decisions related to purchasing, design, development, manufacturing production control activities and other aspects of the quality management system."

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