NSF Logo
Contact us

ISO 14971:2019 - Risk Management for Medical Devices and IVDs - Practical Application

Dates

Times

2 days – 16 hrs VILT

Location

Virtual Learning

Availability

Register
Get in-house medical device risk management training delivered to your team. Contact us.

About This Course

ISO 14971:2019 provides guidelines for manufacturers to establish, document and maintain a risk management process to identify hazards, estimate and evaluate the risks associated with the identified hazards, control risks and monitor the effectiveness of the controls. An effective risk management program applies to all stages of the medical device lifecycle and is an integral part of a manufacturer’s quality management system.

This instructor-led two-day course presents the key foundations of the risk management process defined in ISO 14971:2019 and provides expert tips on how to navigate the process.

This course is highly interactive and includes practical instruction, case study exercises and a competency assessment.

This course also includes a self-paced two-hour ISO 14971:2019 overview eLearning module that must be completed prior to the start of the live instruction.

Key Learning Objectives

At the end of this training, learners will be able to:

  • Identify regulatory requirements for risk management:
    • European Regulation EU 2017/745 (EU MDR)
    • European Regulation EU 2017/746 (EU IVDR)
    • 21 CFR 820.30(g)
  • Identify requirements of key International Standards relative to risk management:
    • ISO 14971:2019
    • ISO 13485:2016
  • Recognize risk management definitions and principles
  • Identify how risk management affects quality management system practices
  • Recognize one method for the practical application of risk management principles

Who Should Attend

This course is vital for any medical device professional looking to expand their knowledge of comprehensive risk management processes and their interactions with the entire lifecycle of a medical device from conception to decommissioning and disposal.

Tutors

Course tutors selected from the following:

James Pink - James Pink has over 20 years of experience in the medical devices industry including 10 years as a health care technology expert and lead auditor for a leading European notified body. He began his career as a product designer in the oil tools industry moving into medical physics and clinical engineering at the Royal Hallamshire Hospital in Sheffield, UK. His industry experience includes managing product development and quality assurance programs for active and non-active implantable and combination products. Mr. Pink is a contributor to several medical device standards committees including ISO 13485, ISO 14971, and various product-related standards.

  • There was a perfect balance of interaction. Some participants had very specific questions relating to their own company's products. The instructors were generous with their advice and it was good that there was enough time for them to comment. It was interesting to hear about how the regulations applied to specific situations in different industries.
  • My incoming questions were answered during the class, I have copious follow-up items to consider based on new insight and learning and was able to learn about different devices thanks to the cross-section of participants.
  • The tutors are obviously experts in the risk field and their past FDA and industry experiences added color and perspective to the course material.

Additional Recommended Courses

ISO 13485:2016 - Fundamentals -Medical Devices - QMS - Requirements for Regulatory Purposes

This virtual instructor-led two-day course covers the requirements of ISO 13485:2016, including the intent, meaning, and interrelationship of the ISO 13485:2016 clauses. This course will also introduce learners to ISO 13485:2016 Medical Devices – A Practical Guide. This guide was developed by ISO TC 210 (the developers of ISO 13485:2016) to assist medical device manufacturers in the practical application of the requirements of ISO 13485:2016 within a quality management system. Learners will demonstrate comprehension through individual and group activities throughout the course as well as a final course challenge.

This course pairs well as a prerequisite to Design Controls for Medical Devices and IVDs (2 day).

Ask about our discount pricing when bundling courses together. We can also bring this course to your individual organization through virtual instructor-led or face-to-face training.

By the end of this training you should be able to:

  • Identify key documents to help you understand ISO 13485:2016
  • Recognize the primary elements of ISO 13485:2016
  • Identify terms and definitions relative to the application of ISO 13485:2016
  • Recognize similarities and differences between ISO 13485:2016 and the Quality System Regulation
  • Demonstrate practical application of ISO 13485:2016 requirements through inspection scenarios

Price: $1200.00

Virtual Classroom Training