ISO14155-IVDR Training Bundle
ISO14155 basic training and IVDR update training in a practical combination package
The ISO14155-IVDR Training Bundle is aimed at study personnel involved in medical device studies and in vitro diagnostic devices.Sign up for: ISO14155-IVDR Training Bundle
Content and Objective of the Course
The ISO14155-IVDR Training Bundle was developed for people who, in addition to learning the basics for clinical trials according to the Medical Device Law Implementation Act, also want to specialize in the current requirements for handling in vitro diagnostic devices. You will receive two certificates confirming your participation after the total of 10 modules in the two distinct training courses are finished.
The objective of this training is to equip participants with the knowledge to competently handle the administrative, legal, and ethical requirements necessary to conduct clinical trials with medical devices and in vitro diagnostic devices.
The flexibility, adaptability, and accessibility of this online training are its advantages. Users can complete a training program at their own speed and location. Additionally, they have two months to access the training at any time. Care was taken to ensure the high quality of our online training in accordance with the eLearning standards of the German Medical Association. The online training has been accredited by the Medical Association of Bremen. 22 Continuing Medical Education (CME) points have been assigned.
Instructions for Participants and General Conditions
We would like to briefly introduce the ISO14155-IVDR Training Bundle. The content of this training was compiled by Dr. Andreas Grund based on his 18 years of experience in clinical trials and prepared with the experience and expertise of the GCP-Service team. The training content serves as a practical guide and clarifies widespread issues and misunderstandings that have come up in the recent past.
The online training consists of eight modules, each lasting approximately 60 minutes:
- Introduction: Development of Drugs and Medical Devices
- Basics of Biometrics: Different Study Designs and Sample Size Calculation
- European Legislation on clinical trials with Medical Devices
- The Declaration of Helsinki and ISO14155:2020
- Investigator Responsibilities part 1
- Investigator Responsibilities part 2/ Sponsor Responsibilities/ Audits
- Important Documents of Clinical Studies
- Documentation and Quality Control of Study Data
- Regulatory aspects of In-vitro Diagnostic Medical Device Regulation (IVDR 2017/746)
- Clinical Operational Aspects of ISO 20916:2019
The modules are continuously updated to the most current legal regulations and trends (no liability assumed). Each module consists of a presentation of approximately 45 minutes followed by a multiple-choice test which must be passed. The test consists of 15 questions generated randomly from a pool of 40 questions and takes approximately 15-20 minutes. 80% of the questions need to be answered correctly to pass. After each failed test, the attendees receive a new set of 15 random questions. Three test repeats are possible after which the attendee must start from the beginning. The individual modules can only be processed in order. After completing all modules and tests, the attendees can download and print the training certificate independently. The certificate contains all topics required by the Ethics Committee and competent authorities to prove the qualification of clinical research staff according to ISO 20916. All training modules within a training course must be completed within two months. If the two-month period has expired and the two questionnaires have not been answered correctly, the online training must be restarted.
excl. 19 % Tax
Accredited by: Ärztekammer BremenSign up for: ISO14155-IVDR Training Bundle