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ISO 13485: 2016 QMSMD Awareness


This training course is designed to provide a comprehensive understanding of the Quality Management System for medical devices. It is specifically tailored for individuals involved in various aspects, such as development, production, storage and distribution, installation, servicing, and final decommissioning and disposal of medical devices. It also covers individuals engaged in design and development, as well as the provision of associated activities like technical support.

The primary objective of this training is to equip participants with the necessary knowledge to comprehend the scope and application of ISO 13485:2016 to ensure compliance with the Medical Device Regulations

Course Objective 

  • To offer a comprehensive overview and interpretation of the ISO 13485:2016 clauses.

  • To enable participants to understand the scope and application of ISO 13485:2016 to meet the requirements of the Medical Device Regulations.

  • To emphasize the significance and importance of ISO 13485:2016 in the medical device industry.

  • To enhance participants' understanding of the specific requirements outlined in ISO 13485:2016.

Target Participants 

Management, Managers, Executive Level, Technical Staffs, Supervisors, Engineers, Medical device manufacturers & medical device industry players.

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