29. September 2020
Workshop: Introduction to product developement and regulatory affairs
Do you want to understand how product development and regulatory affairs (MDR/IVDR) need to work together to successfully bring products to market?
If the answer is a ‘yes’, this workshop by Nila-Pia Rähle is for you. The course will provide participants with an overview of the regulatory landscape for medical devices in Europe (MDR/IVDR) and will also touch upon different aspects for the US market. Participants will get a good understanding of the product development process, as well as the requirements regarding technical documentation.
Register now – space is limited! (more…)
24. September 2020
Workshop: Bringing your project to success while mastering the challenges of IVDR (in-vitro diagnostics)
The goal of this workshop is to give an overview of the regulatory landscape for in- vitro diagnostics medical devices in Europe (IVDR), the product development process, as well as the requirements regarding technical documentation. Within the IVDR the workshop will focus on the development of medical devices and software.