Only registrations for online participation are possible.
target group
Medical device manufacturers, QM managers and regulatory affairs.
content
According to the European regulations for the conformity assessment of a medical product, the suitability for the intended purpose must be proven and an assessment of the medical risks must be carried out. The requirement to prepare a clinical evaluation applies regardless of the medical device class. Under certain circumstances, the clinical evaluation can be carried out using published data on comparable products and medical fields of application. For certain medical devices, this option offers a safe and efficient way of examining the benefits and risks of the product in the context of scientific publications and data. For innovative medical devices and high-risk products, however, a clinical test may be necessary for the clinical evaluation and for the conformity assessment procedure. The seminar gives an overview of the legal basis, the procedure of clinical evaluation and under which circumstances the literature route is appropriate. The regulations and requirements of a clinical trial for medical devices according to DIN EN ISO 14155 are considered accordingly.
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
previous knowledge
Not mandatory.
KONTAKT:
Max-Planck-Straße 17, TuttlingenBeruflichen Bildungsstätte Tuttlingen & Online
