June 2024

Small MedTech companies in Europe face a multifaceted array of challenges, including navigating complex regulatory landscapes, securing funding, protecting intellectual property, and managing manufacturing processes. These companies also need to stay updated with rapid technological advancements, ensure compliance with regulations, and achieve clinical adoption and market access amidst stiff competition. These obstacles highlight the intricate […]

In the previous article about ISO 13131, our Data Privacy expert Roland Schnitter explored the structure and content of this standard. He also examined how ISO 13131 interfaces with quality management system standards like ISO 13485 and ISO 27001 and discussed the potential for effort reduction through the elimination of redundancies. So, how does ISO