You're invited to the first SPARK Studio workshop on 13th Feb at 4 PM!
Led by industry experts, SPARK The Midlands has organised a series of lectures and workshops called SPARK Studio to promote innovation in healthcare technology in the region.
In this workshop, we will discuss the importance of a quality management system (QMS) in the early stages of medical device design. Despite popular belief, a well-established QMS can streamline processes and reduce the time, effort and cost associated with regulatory approvals. We will dive into the basics of quality, QMS, discuss the associated costs and benefits, and touch on ISO 13485 certification. The Workshop is designed for those involved in the entire lifecycle of bringing a medical device to market, from concept to obtaining the CE mark.
Henry Sibun, a medical devices industry consultant and IRCA registered lead auditor for medical device quality management systems, brings a wealth of experience. With a background in auditing numerous medical device and pharmaceutical companies against ISO 13485 and medical devices regulations, he now focuses on assisting companies in obtaining certification and CE marking. For additional details about Henry, please refer to this link.
A team of scientists led by the head of the research group at the Department of Biology, Nicola Silva, has made a significant achievement in research into the reduced or impaired function of the Synaptonemal complex, which may be one of the causes of sterility. The paper by an international team of authors was published in the prestigious scientific journal Nature Communications in March 2025.
SPARK Europe Webinar Series | 2nd April 2025 |4-5 pm (CET) | Regulatory considerations of C&G Therapies | Suzanne Einmahl | hosted by SPARK Zürich
