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The Kelmac Group® has developed a unique tradition of creating learning services that shape the future of conformity and compliance learning solutions for Executive Management, Practitioners and Auditors. 

Where others train followers, we train leaders™

Medical Devices Risk Management Overview based on ISO 14971:2012 Training Course

Course Overview Who is this course for?

This learning event is aimed at those looking to gain a comprehensive understanding of Medical Device Risk Management based on ISO 14971:2012.

Course Basics What is essential to know?

  • This is a 2-day (18hr) learning event.
  • Start/Finish Times: 08:00am – 17:30pm (each day)

 

Medical Devices Risk Management Overview based on ISO 14971:2012 Training Course
 Where are you looking to attend this training?

We are sorry but there are currently no public training dates available for this course at the moment! If you would like to send us your details, we will contact you when a course becomes available near you. If you have any questions about this course, call +353.61.491224.

Course Learning TopicsWhat does the course cover?
  • Course Introduction

    • Introduction and Welcome Workshop objectives and program
    • Introduction to Quality Risk Management
    • ISO 14971:2012 Requirements
    • Introduction to ISO 14971 including the differences between ISO 14971:2007; ISO 14971:2009 and ISO 14971:2012; Overview of the Risk Management Process; Responsibilities; and Requirements of ISO 14971:2012 [Risk Assessment and Control]
    • ISO 14971:2012 Requirements
    • Requirements of ISO 14971:2012 continued [Risk Documentation, Risk Communication and Risk Monitoring and Effectiveness Review]
    • Risk Management Methodologies and Tools Risk Management Methodologies; Risk Management Tools and techniques
    • Application of Quality Risk Management Case Study - Impact of ISO 14971 on the Medical Device Organization/Product Life Cycle
    • Discussion and Q+A
    • Summary and Close

*Kelmac Group cover this topic in more depth compared to our competitors.
**Kelmac Group proven added value as this material is not covered by the IRCA specification or our competitors.

Course Certification

This course is fully certified by Kelmac Group.

How Will I Be Assessed?

The delegate is assessed based on participation and performance throughout the duration of the course. This includes all exercises, role plays, case studies and all other activities during the course. Please note, full attendance is required during the training course.

Who Should Attend?
  • Quality Managers
  • Quality Control Professionals
  • Healthcare Consultants
  • Medical Device Consultants
  • Senior managers
  • Product designers
  • Regulatory affairs professionals
  • Clinical affairs professionals
  • Manufacturing operations personnel
  • Professionals in the Medical Device Industry & Supply Chain

    No review available.

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  • Available Nationwide
  • Tailored to you
  • Fixed Fees, No Expenses*
  • Groups of 5+
  • *Exclusions, T&Cs apply

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The Kelmac Group® has developed a unique tradition of creating learning services that shape the future of conformity and compliance learning solutions for Executive Management, Practitioners and Auditors. Where others train followers, we train leaders™

Course Summary
Course Summary
Course type : Classroom
Course Duration : 14 hours
Certification :
Continuing Education : units
How Will I Be Assessed?

The delegate is assessed based on participation and performance throughout the duration of the course. This includes all exercises, role plays, case studies and all other activities during the course. Please note, full attendance is required during the training course.

Who Should Attend?
  • Quality Managers
  • Quality Control Professionals
  • Healthcare Consultants
  • Medical Device Consultants
  • Senior managers
  • Product designers
  • Regulatory affairs professionals
  • Clinical affairs professionals
  • Manufacturing operations personnel
  • Professionals in the Medical Device Industry & Supply Chain
0 Reviews

No review available.