ISO 14971:2019 Awareness Training

about the ISO 14971:2019 course

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 analyzing 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.

Duration: 2 Days
Language: English

what will you learn from the course?

Upon completion, participants will be able:

• 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 

Topics to be covered in the course include:

• 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 
  

WHAT IS THE COURSE METHODOLOGY?

There is a balance between knowledge-based presentation, discussions, exercises and case studies.

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 details:

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.

WHO SHOULD take the course?

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

Prerequisites: None