Course Programme:  IA training ​ISO 13485:2016​​ Requirements​ ​

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Course Dates: 11th & 13th SEPT 2017


Venue:  814 B-wing | LODHA Supremus 2 , Road # 22 | Wagle Estate | Thane 400 604


Course Fee:  INR 15,000 Inclusive GST , breakfast lunch , course material and certificate


What is ISO 13485?


ISO 13485, Medical devices— Quality management systems – Requirements for regulatory purposes, addresses the development, implementation and maintenance of a QMS intended for use by medical device manufacturers and suppliers. The standard details requirements for a QMS that meets customer requirements and allows the incorporation of applicable regulatory requirements within an organisation’s QMS.


The ISO 13485 revision

The revision of ISO 13485:2003, the ISO working group responsible for the revision faced the significant task of addressing nearly a decade of changes in technology and regulatory requirements. The revised standard ISO 13485:2016 was published on 1st March 2016.


The new edition was issued to respond to the latest developments in quality management, technology, and regulatory requirements.


With the standard applicable to so many types of products, the revision was no easy task. A medical device is any product intended for use in the diagnosis, prevention, and treatment of medical conditions. They range from simple products like wound dressings to dentist chairs, cardiac pacers, life-support machines, and even in vitro diagnostic reagents.



The new standard includes improvements such as broadening its applicability to include all organizations involved in the life cycle of the product (from concept to end of life), greater alignment with regulatory requirements, and a greater focus on post-market surveillance, including complaint handling. There is also a greater emphasis on having the appropriate infrastructure, particularly for the production of sterile medical devices, and more focus on risk management.


Requirements Applicability:

The processes required by ISO 13485:2016 that are applicable to the organization, but are not performed by the organization, are the responsibility of the organization and are accounted for in the organization’s quality management system (QMS) by monitoring, maintaining, and controlling the processes.


If applicable regulatory requirements permit exclusions of design and development controls, this can be used as a justification for their exclusion from the QMS. These regulatory requirements can provide alternative approaches that are to be addressed in the QMS. It is the responsibility of the organization to ensure that claims of conformity to ISO 13485:2016 reflect any exclusion of design and development controls.




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