Trainings
All trainings also available as online trainings!
One step ahead through knowledge and qualification.
We offer you specific trainings, which address different topics, to enhance your quality and efficiency of all stages of clinical projects.
All trainings include the requirements of the MDR. The training fee is reduced by 100€ for online trainings. The trainings can be held in German or English.
New interactive training for MDR and ISO 14155
In this concise and practical course, you will learn about the Medical Device Regulation (EU-MDR) and ISO 14155:2020-07. It transfers interactively the necessary knowledge for the planning, implementation and evaluation of clinical trials with medical devices.
With the MDR toolkit you gain step-by-step insight into medical device regulation during the 3 phases of a clinical trial. In a case-based and attractive way, you will learn about real-time planning, obstacles and challenges. After completion of the course you have gained the knowledge to participate in Medical Device trials and to be working completely EU-MDR (2017/745) and ISO 14155:2020 compliant.
Quick overview
- 1. Self-paced
- 2. 24 hours available
- 3. Language: English
- 4. Certificate
Clinical Research under MDR and ISO 14155:2020
One-day training for planning, execution and evaluation of clinical trials including hands-on workshop (Flyer).
- on request
Clinical studies with medical devices (according to DIN EN ISO 14155:2021-05 and MDR)
This one-day training covers both, the principles and all relevant practical aspects for medical device manufacturers who want to carry out clinical studies. (Flyer)
- on request
PMCF in accordance with MDR and MDCG
This half-day intensive seminar provides you with comprehensive information on the topic of PMCF, taking into account the latest requirements of the MDR and MDCG.
MDR/Medical Device Law Implementation Act (MPDG) investigator training (according to German Medical Association/Working group medical Ethic Committees from April 2022)
MDR/MPDG-Basic training (1 day)
- on request
MDR/MPDG-Advanced training (1 day)
- on request
MDR/MPDG-Refresher training (half day)
- on request
AMG/GCP investigator training (according to German Medical Association/Working group medical Ethic Committees from April 2022)
AMG/GCP-Basic training (1 day)
- on request
AMG/GCP-Advanced training (1 day)
- on request
AMG/GCP-Refresher training (half day)
- on request
- on request
Monitoring of medical device studies – Training for CRAs
This training imparts knowledge about relevant fundamentals of medical devices and clinical trials, the difference between the monitoring process of drug trials and medical device trials, as well as the explanation of practice-oriented aspects. (Flyer)
- on request
Clinical evaluation of medical devices according to MEDDEV 2.7/1 Rev. 4
The MEDDEV 2.7/1 regulation comprises detailed but challenging instructions for the preparation of a clinical evaluation, which were also included in the MDR. We offer a one-day intensive seminar which gives you all essential information for preparing a clinical evaluation independently. (Flyer).
- on request
Publication of clinical study data
The training enables you to write, assess and publish a manuscript conform with regulations. One focus is the optimal use of your study data combining your scientific goals and marketing goals as best as possible. (Flyer)
- on request
Labquality offers a range of trainings tailored to the needs of start-ups. A total of 14 trainings cover the entire range of regulatory requirements to be observed in the field of medical devices.
We also offer individual trainings that are adapted to your specific needs. If requested, we can conduct all trainings at place and/or time of your choosing.
To participate in an online training, the following technical requirements should be met:
- Computer, Laptop, Tablet
- Stable internet connection
- Internet Explorer (at least 8.0), Mozilla Firefox, Google Chrome or Safari
- Headset or at least speackers
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