Medical Devices Risk Management: ISO 14971

Manage risk effectively and see business success with our Introduction to Risk Management for Medical Devices Training Course – an essential and international accreditation for all medical device manufacturers.

The ISO 14971 standard outlines how to identify, evaluate and control risks associated with medical devices throughout the product lifecycle and we can help you implement a risk management framework to achieve ongoing compliance.

Our course is delivered by professionals with unrivalled practical experience and designed to help you get to grips with ISO 14971. In just one day you will understand how the standard can improve risk management within your business, as well as drawing links with quality management standard ISO 13485. You will take away the tools to confidently manage risk to an international standard.

Who should attend?

  • Those working in regulation, quality, development and design
  • Those working in manufacturing and marketing
  • Those responsible for management system strategy decisions
  • Internal auditors

Learning objectives

  • Identify the links between ISO 13485 and ISO 14971
  • Learn how risk management applies to the product lifecycle
  • Define risk management terminology and objectives
  • Outline and lead the ISO 13485 risk management process
  • Gain CPD points and professional recognition

Course Benefits

  • Be confident your medical devices are compliant
  • Ensure compliance continues throughout product lifecycle
  • Gain competitive advantage through accreditation
  • Increase market access and customer confidence
  • Encourage professional development and build risk awareness

Next Steps

  • Lead Auditor: ISO 13485 - Review ISO 13485 and build on the principles of process auditing in accordance with quality management system standards. Work with our training experts to understand the entire audit process at lead level from planning, to managing and reporting on audit results
  • Introduction to: CE Marking - Gain an introduction to the Medical Device Directives and understand their background and key features. On completion of this course, you'll be able to make informed decisions on meeting the requirements of medical device directives, identify the steps required to reduce the risks in the regulatory process and bring products to the EU market much quicker