Content
According to the European regulations for the conformity assessment of a medical device, the suitability for the intended use must be proven and an assessment of the medical risks must be carried out. The requirement to prepare a clinical assessment applies regardless of the medical device class. The clinical evaluation can, under certain circumstances, be carried out using published data on comparable products and medical applications. For certain medical devices, this option offers a safe and efficient way to examine the benefits and risks of the product in the context of scientific publications and data. However, for innovative medical devices and high-risk products, a clinical test may be necessary for clinical evaluation and the conformity assessment procedure.
The seminar provides an overview of the legal basis, the process of clinical assessment and under which circumstances the literature route is appropriate. Accordingly, the regulations and requirements of a clinical test for medical devices are considered in accordance with DIN EN ISO 14155.
Topic overview
- Legal basis
- Structure and content of a clinical evaluation
- Need for clinical trials
- Clinical testing according to DIN EN ISO 14155
- Definition and necessity of post-market clinical follow-up studies
target group
Medical device manufacturers, QM managers and regulatory affairs.
Prior knowledge
Not required.
Funding opportunity
ESF funding is possible. Further information can be viewed here .
Early bird discount
If you register up to 3 weeks before the start of the seminar, you will receive an early bird discount of 10 percent.
KONTAKT:
TuttlingenTuttlingen & Online
