Home Requirements of ISO 14971: Risk Management for Medical Devices

Requirements of ISO 14971: Risk Management for Medical Devices

This training will help you identify the hazards associated with a medical device and assess and evaluate the risks associated with its intended use as well as any reasonably foreseeable misuse. It will also guide you in developing a risk management dossier that complies with the principles of ISO 14971, using a methodical and structured approach.

Video
Learning Objectives

By the end of this training, you will be able to:

  • Understand the key concepts of risk management within the framework of ISO 14971 and Regulations 2017/745 or 2017/746
  • Identify and analyze the risks associated with medical devices throughout their lifecycle.
  • Document and maintain risk management activities to meet regulatory requirements.
  • Quality Manager
  • Regulatory Affairs Manager
  • Project Manager
  • Design and Development Engineer
  • Any person involved in risk assessments of medical devices
  • Familiarity with EU Regulation 2017/745 (MDR) or EU Regulation 2017/745 (IVDR) and the ISO 13485 standard is recommended.
  • Format: virtual or in-person class
  • In-house training available: please contact us
  • Registration deadlines: Registration closes 24 hours before the session. Maximum of 10 people. Minimum of 3 people.
  • Accessibility: Accessible to everyone. If you require special accommodations due to a disability, please contact us.

Training Program

  • Background and Importance of Risk Management for Medical Devices.
  • Overview of the ISO 14971 standard and its regulatory framework.
  • Key Terms and Definitions
  • Life Cycle of Medical Devices

  • Overview of the Process
  • Risk Management Plan
  • Risk Management Report

  • Identification of hazards and assessment of associated risks.
  • Risk Assessment
  • Risk Acceptability: Criteria and Methodology.
  • Risk Management: Strategies and Mitigation Measures.
  • Assessment of Overall Residual Risk
  • Risk-Reward Analysis

  • Data Collection
  • Post-market surveillance and trends
  • Risk Management Update

Monitoring and Evaluation Procedures

  • Attendance Sheet
  • Mini quiz / practice exercise at the end of each learning objective
  • Final Review Quiz at the End of the Training Course
  • Satisfaction Survey
  • Training Certificate

Technical and Educational Resources

  • Technical Requirements: Microphone, webcam, and internet connection required; a Microsoft Teams link will be sent 24 hours before the workshop.
  • Methods Used: Training materials provided to trainees by the instructor. Practical exercises, discussions, and sharing of experiences.

Speaker

Medical Device Trainer: Significant professional experience in the field of medical devices >5 years.