sitem-insel AG
During the MDR Readiness Day, manufacturers will have the opportunity to exchange ideas, answer open questions themselves and find out important discussion areas for them in the areas of development, technical documentation, registration, and market surveillance. Topics to be analyzed in depth by industry representatives will be dealt with in the subsequent MDR Support Panel.
With the new MDR, the clinical evidence requirements for Class IIb and III products are increasing substantially. Find out how you can generate this evidence efficiently.
During the MDR Readiness Day, manufacturers will have the opportunity to exchange ideas, answer open questions themselves and find out important discussion areas for them in the areas of development, technical documentation, registration, and market surveillance. Topics to be analyzed in depth by industry representatives will be dealt with in the subsequent MDR Support Panel.
Own-brand-labeler (OBL), manufactures using hazardous substances, manufacturers of combination products or software developers will face many new challenges with the new MDR. Find out what you need to pay attention to in your products.
The third Swiss MDR/IVDR Forum will explain for which products you need clinical data and how you can obtain them: What information is required to obtain an adequate clinical evaluation? What requirements do they have to meet?
During the MDR Readiness Day, manufacturers will have the opportunity to exchange ideas, answer open questions themselves and find out important discussion areas for them in the areas of development, technical documentation, registration, and market surveillance. Topics to be analyzed in depth by industry representatives will be dealt with in the subsequent MDR Support Panel.
Reusable low-risk surgical medical devices now belong to the Ir (reusable) class. There is no transitional period for these products, so they must have undergone the new procedure by May 2020. This presents the industry with great challenges.