ISO 14155:2020 CLINICAL INVESTIGATION OF MEDICAL DEVICES FOR HUMAN SUBJECTS UPDATE – BRIDGING THE WAY TO THE EU MDR TRAINING 04.02./11.03./12.04./18.05./09.06./09.07./22.09./20.10/17.11.2021
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The ISO 14155:2020 is the third edition and introduced higher requirements to conduct clinical investigations of medical devices for human subjects with regards to the EU MDR 2017/745 and ISO 14971:2019 – Application of risk management. To ensure that you are fulfilling the requirements of this international standard on the road to MDR, we are offering detailed insight about the requirements, their backgrounds, and links to risk management and MDR as well as the best way to show compliance. This training will help you facilitate your gap analysis by obtaining the knowledge to plan the implementation process of the standards and understand the key elements required to plan and conduct the clinical investigation
• Opening Remarks
• Why do we need more and more clinical data and clinical investigation?
• Overview of main changes in ISO 14155:2020
• Ethical considerations
• Clinical investigation planning
• Conducting clinical investigations
• Suspension, termination, and close-out of the clinical investigation
• Responsibilities of the sponsor
• Responsibilities of the principal investigator
• New Annexes (normative & informative)
• Q&A session
• Closing remarks
- Start 08:30 AM – End 05:30 PM. Attendees are recommended to login 15 min in advance.
In order to keep the training interactive, the exact content schedule cannot be provided.
Certification:Personal Certificate will be provided in PDF
Presentation:Presentation will be provided in PDF