In close cooperation with Holland Innovative, SBMC organizes a series of three workshops about standards and regulation applicable for the development of biomaterials for regenerative medicine.
In this series we will first lay the ‘Fundament in Regulatory’. We will start by explaining the basic structure behind CE marking, Medical device regulations and standards. Following we will make the step to combination products; drugs & devices and corresponding regulations. Attention is paid to quality management systems & technical documentation. In the second day we will make sure that your development project is set-up in structured manner, ready to deliver a compliant product.
From your own Design & Development process, starting with a well-defined project, to setting up requirements, to finally verification & validation of your product and process. In the third day we will focus on core elements: Risk management for both medical devices & medicinal products, Usability engineering & Clinical evaluation & investigation.
All 3 workshops are a good mix of theory combined with practice, which means that there is time to apply the theory in practise on the medical devices currently developed by the participants, using templates of Holland Innovative. All workshops are fully booked. After evaluation, a new series will start in the spring of 2023.
If you want to stay informed, send a message to Olga Liska.
