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