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ISO 14155Clinical investigation of medical devices for human subjects
Good clinical practice

Expert Lecturer: Ms. Gali Vino
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It is well known that the design and conduct of a clinical investigation should be done under good clinical practice (GCP) to ensure the proper scientific conduct and the integrity of the results, and to protect the rights, safety, and well-being of the human subjects involved in the investigation. The most known GCP guideline is the ICH E6(R2), which was...Continue reading

It is well known that the design and conduct of a clinical investigation should be done under good clinical practice (GCP) to ensure the proper scientific conduct and the integrity of the results, and to protect the rights, safety, and well-being of the human subjects involved in the investigation. The most known GCP guideline is the ICH E6(R2), which was issued by the International Council for Harmonization (ICH) of Technical Requirements for Pharmaceuticals for Human Use, however, as hinted by the organization name, this guideline focuses on clinical investigations of pharmaceutical products.

The GCP guideline for clinical investigation of medical devices is ISO 14155, which defines the state-of-the-art approach for the clinical development strategy for medical devices with the purpose of gathering, recording, analyzing, and reporting relevant data on the quality, performance, and safety of a device throughout its entire life cycle.

This course provides an overview of ISO 14155:2020 and presents practical guidance on how to implement the requirements of the standard in various types of clinical investigations of medical devices.

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Date:  7 September, 2025

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    Course location: Hybrid: Kiryat Weizmann Ness Ziona or ZOOM
    Duration: 1-Day Course
    Hours: 09:00 - 17:00
    Credits:
    Course Language: עברית

    Course price: 2,300 NIS + VAT
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    Issues to be covered

    • Background and history of ISO 14155
    • Introduction to ISO 14155 sections and annexes
    • Overview of similarities and differences between ISO 14155:2020 and ICH E6(R2)
    • Position of ISO 14155 in the regulation of medical devices
    • Implementation of ISO 14155 in pre- and post-market clinical investigations

    Who should attend

    • Individuals who are involved in designing and executing clinical investigations of medical devices
    • Regulatory affairs, quality management, and clinical affairs personnel from medical device companies and clinical institutions

    Benefits to the Participants

    Participants in this course will:

    • Learn about the GCP principles for medical device investigations
    • Understand the similarities and differences between ISO 14155 and ICH E6(R2)
    • Comprehend the role of ISO 14155 in the context of medical device regulations
    • Get tools and tips for the implementation of ISO 14155

    About The Lecturer

    Gali Vino
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