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Home » Combined ISO 14001:2015 and ISO 45001:2018 Lead Auditor Training » Medical Devices Risk Management Overview based on ISO 14971:2019 Training Course

Medical Devices Risk Management Overview based on ISO 14971:2019 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 14971:2019.

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

Course Basics What is essential to know?

  • This is a 1-day (8hr) learning event.
  • Start/Finish Times: 08:00am – 17:30pm (each day)

 

 Where are you looking to attend this training?

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Course Learning TopicsWhat does the course cover?

  • Course Introduction

    • Introduction and Welcome Workshop objectives and program
    • Introduction to Quality Risk Management
    • ISO 14971:2019 Requirements
    • Introduction to ISO 14971 including the differences between ISO 14971:2007; ISO 14971:2009 and ISO 14971:2019; Overview of the Risk Management Process; Responsibilities; and Requirements of ISO 14971:2019 [Risk Assessment and Control]
    • ISO 14971:2019 Requirements
    • Requirements of ISO 14971:2019 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?

Each Learner 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



  • Cian O'Sullivan Attended this course in September 2015

    Good knowledgeable course with a strong focus on the importance of procedures and documents associated with Risk Management. Interaction with course coordinator and other course attendees was a plus rather than observing endless slides.

    Cian O'Sullivan | Attended this course in September 2015

  • Gerry Campbell Attended this course in July 2014

    Very good course and extremely good instructor.

    Gerry Campbell | Attended this course in July 2014

  • Carol O'Sullivan Attended this course in December 2018

    .

    Carol O'Sullivan | Attended this course in December 2018

  • Con Connolly Attended this course in September 2015

    The trainer left us in know doubt that risk analysis is a very important part of the manufacture of medical products especially from a legal view point. He gave a detailed review of the different medical standards and what changes were coming down the line in the next year.

    Con Connolly | Attended this course in September 2015

  • Marie Claffey Attended this course in September 2015

    Informative course that requires active participation to get the most benefit.

    Marie Claffey | Attended this course in September 2015

  • Ronan Kennelly Attended this course in July 2014

    The course was extremely helpful in terms of an overview of the 14971 standard, but was complimented by an experienced instructor who has experience of the on-going audit process. I would certainly recommended this as a starting point for professionals who have to work in conjunction with these requirements.

    Ronan Kennelly | Attended this course in July 2014

  • Siofra Caherty Attended this course in July 2014

    Course was detailed and indepth. Good mixture of group activities and self directed study.

    Siofra Caherty | Attended this course in July 2014

  • Thomas Moore Attended this course in September 2015

    The course provided attendees with a very good understanding of the need for risk management and the process of risk management.

    Thomas Moore | Attended this course in September 2015

  • Patrick Dowling Attended this course in October 2018

    Session encouraged overall discussion rather than section-by-section breakdown of ISO 14971

    Patrick Dowling | Attended this course in October 2018

  • Ronan Burns Attended this course in October 2018

    Good - Interesting Tutor managed to keep it interesting

    Ronan Burns | Attended this course in October 2018

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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 Details Student Reviews Related Courses
Course Summary
Course Summary
Course type : Classroom
Course Duration : 8 hours
Certification : Kelmac Group
Continuing Education : units
How Will I Be Assessed?

Each Learner 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



8 Reviews

Cian O'Sullivan

Attended this course in September 2015

 

Good knowledgeable course with a strong focus on the importance of procedures and documents associated with Risk Management. Interaction with course coordinator and other course attendees was a plus rather than observing endless slides.

Gerry Campbell

Attended this course in July 2014

 

Very good course and extremely good instructor.

Carol O'Sullivan

Attended this course in December 2018

 

.

Con Connolly

Attended this course in September 2015

 

The trainer left us in know doubt that risk analysis is a very important part of the manufacture of medical products especially from a legal view point. He gave a detailed review of the different medical standards and what changes were coming down the line in the next year.

Marie Claffey

Attended this course in September 2015

 

Informative course that requires active participation to get the most benefit.

Ronan Kennelly

Attended this course in July 2014

 

The course was extremely helpful in terms of an overview of the 14971 standard, but was complimented by an experienced instructor who has experience of the on-going audit process. I would certainly recommended this as a starting point for professionals who have to work in conjunction with these requirements.

Siofra Caherty

Attended this course in July 2014

 

Course was detailed and indepth. Good mixture of group activities and self directed study.

Thomas Moore

Attended this course in September 2015

 

The course provided attendees with a very good understanding of the need for risk management and the process of risk management.

Patrick Dowling

Attended this course in October 2018

 

Session encouraged overall discussion rather than section-by-section breakdown of ISO 14971

Ronan Burns

Attended this course in October 2018

 

Good - Interesting Tutor managed to keep it interesting

View All

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