ISO 10993-1:2025 – Understanding the Updates in Biological Evaluation and Risk Management

Course Details

Event Scheduled: On request
Learning Mode: Online
Language: English
(see more details below)

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Learning Objectives

The new ISO 10993-1:2025 introduces key updates to the biocompatibility assessment of medical devices and strengthens its integration with the Risk Management System (ISO 14971) through a more structured and integrated approach.

 This Medical Update provides a clear overview of the main changes, showing how biological evaluation is evolving and what manufacturers and professionals involved in regulatory compliance and biological safety should expect

Who will benefit?

Participants will learn to interpret the updated standard, understand the reasons behind the changes, and assess their practical impact on compliance activities, technical documentation, and test planning.

Course Agenda

• Introduction and Objectives
• Overview of the Key Updates of ISO 10993-1:2025
• Strengthened integration with the Risk Management System
• Biological Evaluation: Technical Updates and Practical implications
• Q&A and Closing

 At the end of the course, a Certificate of Attendance will be issued.

Prerequisites

As this is an advanced course, a thorough knowledge of the European directives in the field of medical devices (MDD 93/42/EEC and subsequent updates) is required.

Teaching 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

At the end of the course, a Certificate of Attendance will be issued.

Duration

4 hours.

Scheduled Events

• Events will be planned on request (and published on this page).

Price

190,00 € (per participant, taxation excl.)

Learning Mode

Online, Instructor-Led.
The course is held by a qualified TÜV Italia Akademie trainer.

Language

Training in English Language