ISO 13485 Documents for Medical Devices – Documentation Consultancy

ISO 13485 is an international standard was first published in 1996 for Medical devices – Quality Management Systems. It presents the requirements for a comprehensive quality management system for the design and manufacturing of medical devices.
ISO 13485 requires that certified organization demonstrates the quality system is effectively implemented and maintained. We offer ISO 13485:2016 Documentation Toolkit that contains a complete set of mandatory and supporting ISO 13485 documents.
We assist organization with the use of our ISO 13485 documents for better implementation and auditing of implemented systems.
All our resources and toolkit are developed under the guidance of expert consultant who has vast experience in the field.

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