Risk Management for Medical Devices (ISO 14971)

Course Details

Scheduled Events: June 2026
Learning Mode: Online
Language: English
(see more details below)

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Learning Objectives

• Provide the operational tools required for effective Risk Management applied to both active and non-active medical devices and in vitro diagnostic devices.
• Manage Safety Risks associated with medical devices and in vitro diagnostic devices in relation to their Benefits and the generally recognised State of the Art throughout the entire product lifecycle.
• Illustrate and discuss with participants:
  • The requirements of the EN ISO 14971:2019+A11:2021 standard harmonised with EU Regulations 745/2017 (MDR) and 746/2017 (IVDR).
  • Examples of practical application of the ISO 14971 standard requirements.

Who should attend?

Designers (non-active devices, active hardware/software devices, in vitro diagnostic devices), product and process engineering teams, quality system and product certification managers, regulatory affairs managers, consultants.

Course Agenda

• Regulatory framework: application of EN ISO 14971:2019+A11 within the context of the EU MDR and IVDR regulations.
• Definitions, terminology, and fundamental concepts.
• Risk Acceptability Policy.
• Risk Management Plan.
• Phases of the Risk Management process:
  • Risk Analysis and Risk Estimation
  • Risk Evaluation
  • Risk Control
  • Evaluation of Residual Risks
  • Overall Residual Risk Evaluation
  • Acceptability of the Benefit–Risk Ratio
  • Risk Management Review and management of Production and Post-Production information
• Additional in-depth topics, including:
  • The concept of the generally recognized State of the Art
  • Addendum A11:2021 and the application of ISO 14971 to MDR/IVDR mandatory requirements
  • Overview of “Usability” concepts applicable to Risk Management
• Application examples:
  • Practical exercises to apply the principles discussed.

Prerequisites

Knowledge of EN ISO 13485:2016/A11:2021 and basic understanding of EU Regulations 745/2017 (MDR) or 746/2017 (IVDR).

Participation in the courses dedicated to ISO 13485 and, depending on the technical area of interest, to the EU MDR or IVDR Regulations is recommended.

Course Materials

• Handout, containing the slides projected during the course, in case of online courses it will be provided in electronic format;
• Notebook for didactic use (where applicable), containing a copy of the standards necessary for the training course, to be returned at the end of the course. In order to respect copyright, all the standards of online courses can be provided for consultation only through access to a dedicated portal. For a higher quality of teaching and preparation for exams (where applicable) it is advisable that participants purchase the reference standard directly from the official ISO store https://www.iso.org/home.html or request a copy within their own organisation.

Learning Assessments

• Certificate of competence, in case of successful completion of final exam
• Certificate of attendance, in case of non successful completion of final exam or no exam.

Duration

8 hours.

Scheduled Events

• 18 June 2026, 09:00 am - 06:00 pm (CEST).

Price

610,00 € (per participant, taxation excl.).

Learning Mode

Online, Instructor-Led

Language

Training in English Language