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ISO 14971: 2019 Awareness Training Program

Awareness Program on Risk Management according to ISO 14971: 2012 Standard

Virtual classes schedule

15th - 16th Nov. 2021: Awareness Program on Risk Management according to ISO 14971:2019 Standard I Duration: 02 Days | Time: 9:30 am to 6:30 pm

WHAT IS ISO 14971:2019?

Implementation of Risk Management is a one of the primary requirements while demonstrating the compliance to regulatory requirements and conformance to Quality Management system requirements to ISO 13485 Standard for Medical Device and In-vitro Diagnostic device manufacturers.

While analysing the reasons for the product failures, most of the time it leads to inadequacy in understanding and implementation of risk management in the organization. This training is to create awareness of requirements and to have better understanding.


  • To have better planning and framework of risk management
  • To demonstrate compliance to regulations
  • To have structured approach while implementation
  • To learn the overview of risk management activities
  • To ensure product development with desired quality and safety standards
  • Integration of risk management into an existing Quality Management System 


  Introduction to ISO 14971:2019 
  Links to regulatory requirements 
  Understanding pf ISO 14971:2019 standard and implementation 
  General requirements for risk management system 
  Risk analysis 
  Risk evaluation 
  Evaluation of overall residual risk 
  Risk management review 
  Production and post-production activities 
  Application of risk management in QMS 


  • Product Risk Managers
  • Quality Assurance
  • Regulatory Affairs
  • Research & Development
  • Project Managers
  • Operations Managers
  • Manufacturing Managers
  • Engineers


02 Days


Participants will be assessed through a 50 marks written examination (open book) at the end of the course. Minimum passing % criteria: 70%.


Participants who score 70% and above in the written examination will be issued a TÜV SÜD South Asia’s course completion certificate. Unsuccessful candidates will be issued a certificate of attendance.

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