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ISO 13485 Training Objectives 

With the ISO 13485 training, you will be able to: 

  • Understand the ISO 13845 requirements
  • Know how to apply the requirements of the ISO 13845  
  • Enable the participants to carry out a road map for the implementation of the requirements of ISO 13845 

By following these standards, you will ensure that your organization are in line with the basic requirements for Medical Devices Industry using the basic requirements recognized worldwide. 

 

What is ISO 13485? 

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.  

Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support). ISO 13485 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. 

Requirements of ISO 13485 are applicable to organizations regardless of their size and regardless of their type except where explicitly stated. Wherever requirements are specified as applying to medical devices, the requirements apply equally to associated services as supplied by the organization. 

 

ISO 13485 training course 

The participants will attend a theoretical training session on the ISO 13485 Standards and a workshop to identify the major gaps between the actual status and the standard requirements.  

The ISO 13485 Standards training workshop will be performed using a gap analysis tool, learning the most important concepts related and developing a high level road-map. 

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