ISO 14155 Clinical Investigation of Medical Devices for Human Subjects – Good Clinical Practice
This training course focuses on good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.
Participants in this course will:
- Learn the basis of ISO 14155
- Requirements for planning and conducting a clinical investigation
- ISO 14155 in the frame of MDR
- Differentiation of the roles and responsibilities of sponsor and the principal investigator
Important: TÜV SÜD tests and certifies through its Notified Bodies medical devices and their manufacturers. TÜV SÜD Akademie GmbH offers trainings in the field of medical devices.
The neutrality and independence of the conformity assessment procedures carried out by TÜV SÜD must be maintained. In the interest of our customers, hence the seminars of TÜV SÜD Akademie do not contain any product-specific, process-related or company-specific content or solutions that could fulfill the function of individual consulting.
In case of any questions or uncertainties, please do not hesitate to contact us at [email protected].
This training course is intended to all professionals involved in clinical research, such as clinical project manager, investigator, study nurse, study coordinator willing to comply with ISO 14155 GCP:
- Clinical Research Professionals
- Clinical Affairs, Regulatory Affairs, Product Management, Business Development, Project Manager
- Medical Device Industry Consultant
- Clinical Investigations Service Provider for Medical Devices
- Authorities
Training Agenda
9:00 -9:30 Welcome and Introduction
9:30-10:00 GCP Basics
10:00-10:30 ISO 14155:2020 Section 1,2,3,4
10:30 – 11:00 ISO14155:2020 Section 5,7
12:00-13:00 Break
13:00- 14:00 ISO14155:2020 Section 6
14:00-15:00 ISO 14155:2020 Section 8
15:00-16:00 ISO 14155:2020 Section 9
16:00-16:30 Summary and closing
16:30-17:00 Test and end of training
The ISO 14155 standard provides the requirements for clinical investigations intended to:
- Protect the rights, safety, and well-being of human subjects,
- Ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,
- Define the responsibilities of the sponsor and principal investigator, and
- Assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
The ISO 14155 standard defines the state-of-the-art approach for the clinical development strategy for medical devices with the purpose to gather, record, and analyze relevant data on the quality, performance, and safety of a device throughout its entire life cycle covering pre-, and post-market phases. The principals set forth in the standard are intended to be followed for pre-market and for post-market clinical investigations, as far as relevant. The clinical development stages outlined include pilot, pivotal and post-market stages, covering interventional clinical investigations such as first in human, feasibility, and pivotal clinical investigations, but also observational and non-interventional clinical investigations.
You will get a complete ISO 14155 Good Clinical Practice training course on Clinical Investigations with Medical Devices for Clinical Research Professionals. Regulatory framework, scope, and principles of ISO 14155.
- World-Class Training
- Learn from TÜV SÜD’s industry expert and training specialists
- Interactive Learning Style
- Interactive formats such as lectures, illustrations and simulations are used
- Networking Opportunity
- Meet and build network with like-minded individuals at our instructor-led training
- Gain A Competitive Edge
- Gain knowledge and develop relevant skills to stay relevant
Instructor-led training in a virtual classroom. This means the course is Live Online. Participants will learn through online teaching. Lectures, case studies, group exercises, discussions, problem solving, examples with explanation, assignments and/or quizzes happen in the virtual classroom training. Participants need to connect to the class from any internet accessible location. Each module is delivered live using webinar technology, creating a virtual classroom learning environment. Live sessions provide you with direct access to the trainer so you can ask questions, understand complex concepts and share ideas with peers. Webcam and microphone are REQUIRED to interact with the instructor and/or other participants.
The course content and structure are designed by the domain experts from TÜV SÜD.
With immense experience and knowledge in the relevant standards, our team of product specialists and technical experts at TÜV SÜD, developed the course content based on current business landscape and market requirements.
Participants must provide their own copy of ISO 14155:2020 for this course. Participants can obtain a copy of the standard at ISO Store online.