Updated Training on ISO 14155:2026 Medical Device Standard
Designing and conducting a clinical trial should be done with Good Clinical Practice (GCP) and quality in mind to ensure the reliability of trial results as well as to follow requirements of regulatory authorities.
Organizations usually understand the necessity of following ICH E6(R3) to ensure GCP; however, there is frequently a gap in training internal teams, contractors, CROs, and sites on ISO 14155:2026 GCP for medical devices. Following the standard is a key part of building globally recognized GCP into the full life cycle of the medical device clinical trial and can complement the current GCP training.
Content includes an Overview of the Standard, Clinical Investigation Planning, Sponsor Responsibilities, Responsibilities of the Investigator, Clinical Investigation Conduct, and Suspension, Termination, and Close-out of Clinical Investigation.
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ISO 14155:2026 Medical Device StandardCourse ID: CP008a |
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Introduction to the Regulation of Medical DevicesCourse ID: MDA0 |
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Quality Management System Requirements for Medical Devices under ISO 13485:2016 and FDA QMSRCourse ID: MD02 |
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Medical Device vs. Drug: Comparing and ContrastingCourse ID: CP010a |
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Assuring Data Integrity in Clinical ResearchCourse ID: ICT03 |
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Standard Operating Procedures (SOPs) in the GxP Regulated IndustryCourse ID: SOP-101 |
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