Application of Risk Management for Medical Devices Training Program

According to ISO 14971: 2019 and ISO/TR 24971:2020

According to ISO 14971: 2019 and ISO/TR 24971:2020

Virtual classes schedule

26th - 27th Sept. 2022: Application of Risk Management for Medical Devices according to ISO 14971:2019 Standard I Duration: 2 Days | Time: 9:30 am to 5:30 pm 

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WHAT IS ISO 14971:2019?

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

While analysing the reasons for the product failures often leads to inadequacy in understanding and implementing risk management in the organisation. This training is to create awareness of requirements and to have a better understanding.

YOUR BENEFITS

This training program will provide participants with an in-depth understanding of risk management standards according to ISO 14971:2019 and ISO/TR 24971:2020. This topic will enable participants to understand how to implement risk management to comply with the regulatory expectations while presenting the technical documentation. Some of the key benefits of enrolling for this training program are as below:

  • Have better planning and framework of risk management
  • Demonstrate compliance to regulations
  • Have a structured approach while implementation of risk management measures
  • Learn the overview of risk management activities
  • Ensure product development with desired quality and safety standards
  • Integration of risk management into an existing Quality Management System 

COURSE CONTENT / OUTLINE

  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 
  Exercise 

WHO SHOULD ATTEND?

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

TRAINING DURATION

02 Days

EXAM DETAILS

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

CERTIFICATION

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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