from | 13-09-202114:00 | ||||
until | 14-09-202117:00 | ||||
duration | 2 days | ||||
special start times
|
place | Medidee Services SA |
city | online, Switzerland |
name | Mr. Raimo SumpMedidee Services (Deutschland) GmbH |
phone | +49 170 96 01 473 |
raimo.sump@medidee.com |
Training objectives:
This training is organized into 2 modules with a duration of 3 hours each with the goal of providing participants with an extended understanding of ISO 14155:2020 – including Good Clinical Practice. The course will enable you to link key regulatory and quality considerations when conducting clinical investigations on medical devices.
The training is aimed at any employee involved in clinical activities who seek to enhance their knowledge and competencies within this field.
Training content:
ISO 14155 addresses the design, conduct, recording, monitoring, and reporting of clinical investigations on medical devices and how to apply GCP when working with human subjects. The standard is established to ensure proper scientific conduct of clinical investigations, as well as protecting the rights, safety, and well-being of the human subjects involved in the investigation. The principles of the standard should be applied to all types of clinical investigations intended to assess the clinical performance, effectiveness, and safety of medical devices.
By attending this training, you will receive in-depth knowledge. For more details please follow the link: