You can’t buy trust. BUILD IT through ISO 13485.
"Demonstrate your ability to supply medical devices through
Quality Management System for Medical Devices - ISO 13485"
ISO 13485 is an ISO standard, published in 2016, that represents the requirements for a comprehensive management system for the design and manufacture of medical devices. ISO 13485 is applicable to organizations that manufacture private label medical devices, in vitro diagnostic medical devices, and medical components.
ISO 13485 is generally harmonized with ISO 9001. A vital difference is that ISO 9001 requires the organization to demonstrate continual improvement, whereas ISO 13485 requires only that they demonstrate the quality system is implemented and maintained. Some of the additional requirements to ISO 9001 requirements relate to:-
This means that compliance with this standard automatically demonstrates compliance with the specific parts of the directives that require a quality management system.
Formal certification of quality management system, specifically for medical devices, to ISO 13485:2016 proves advantageous, for medical companies which export their products to the global market.
Who Can Go For ISO 13485 Certification?
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ISO 13485 implementation leads to:-
Niall offer’s a customized training programme on ISO 13485:2016 for