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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.

Medical Device Act investigator training (according to German Medical Association/Working group medical Ethic Committees)
Medical Device Act-Basic training (1 day)
  • on request
Medical Device Act-Advanced training (1 day)
  • on request
Medical Device Act-Refresher training (half day)
  • on request

AMG/GCP investigator training (according to German Medical Association/Working group medical Ethic Committees)
AMG/GCP-Basic training (1 day)
  • on request
AMG/GCP-Advanced training (1 day)
  • on request
AMG/GCP-Refresher training (half day)
  • on request

Clinical studies with medical devices (according to DIN EN ISO 14155 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

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

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.

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