WET List, Delegated Act and MDR 2.0: Why Manufacturers Now Need a Robust Strategy
On May 27, 2026, the PRO-LIANCE Learning Update Factory took place, focusing on the WET List and the Delegated Act of March 2026. The central question addressed, one that currently concerns many manufacturers of implantable and Class III medical devices, was: What does the planned expansion of the so-called Well-Established Technologies list mean in practice for […]
AI, MDR, and Beyond: Lessons from RAPS Lisbon
Following the recent RAPS Euro Convergence in Lisbon, we sat down with one of our college Dr. Leigh-Anne Dell-Brown to reflect on the key discussions, emerging trends, and practical insights shaping the medical device industry. From the evolving role of artificial intelligence in regulatory processes to the growing emphasis on transparency and patient-centered communication, the […]
PRO-LIANCE GLOBAL SOLUTIONS Joins the EASYGEN Consortium to Bring CAR-T Therapy Closer to Patients
Today, CAR-T therapy stands as one of the most groundbreaking advances in cancer treatment. However, fewer than 20% of eligible patients currently receive this life-saving therapy—primarily due to the centralized, complex, and time-consuming nature of its manufacturing process. This needs to change. We are proud to announce that PRO-LIANCE GLOBAL SOLUTIONS has joined the newly […]