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In This session we have discussed about the ISO 13485:2016 standard which is medical devices quality management system.
We have discussed the origin of MD-QMS, The overall concept of MD-QMS, What is COBIT Framework, Principles of ISO 13485, Benefits of Implementing ISO 13485, Implementation steps of ISO 13485.
MDQMS is an specific standard for medical device industry which fulfils specific needs related to production of a particular medical device such as production control, quality management & regulatory compliances.
The objective of MDQMS i.e. ISO 13485:2016 is to facilitate harmonized and maintains medical device regulatory requirements and the requirements of the Quality management systems. Medical Equipment’s are prone to any defect which causes injury to the public health and it is very dangerous. Therefore ISO 13485:2003 certification provides and boosts a confidence and creates a credibility of the organization in the mind of the stakeholder, Directors and clients.
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