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Medical Device (ISO 13485)

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 regulatory requirements applicable to medical devices and related services including customer requirements. The primary objective of ISO 13485 is to facilitate harmonized medical device regulatory requirements for quality management systems.

Our training courses on quality management system for medical devices ISO13485 are designed to enhances the participants’ learning experience and to achieves a better level of understanding of the ISO13485 standard including in depth coverage of applicable legislation.


OUR FEATURED TRAINING PROGRAMMES

ISO 13485 : Awareness Training Programme 

  • Gain a good understanding of ISO13485 to harmonize the medical devices’ regulatory requirements to Quality Management System with our ISO13485 : Awareness training programme.

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1 Day (8 Hrs)
Classroom based training programme

ISO 13485 : Implementation Training Programme 

  • An effective implementation of ISO13485 is essential for medical device manufacturers if organizations needs to achieve compliance with applicable regulatory requirements.

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2 Days (16 Hrs)
Classroom based training programme

ISO 13485 : Internal Auditor Training Programme 

  • An effective monitoring is essential if organizations needs to achieve and maintain international ISO13485 certification and to continually improve business process performance ensuring continual compliance with regulation and to maximize the customer confidence.

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2 Days (16 Hrs)
Classroom based training programme