On October 1, 2024, Bericah proudly participated in MedGenerAction 2024, held in Bologna. The event brought together industry leaders in Medical Devices to discuss how regulatory compliance and innovation can accelerate the introduction of new devices to the market.
Bericah’s participation confirmed its commitment to promoting advanced technologies and safe solutions.
During the summit, leading experts delved into crucial topics such as cybersecurity and data security, design and innovation in today’s technological context, challenges and opportunities in the development of innovative Medical Devices, the impact of changes in the product lifecycle, and post-market compliance—key issues for a constantly evolving sector.
During the roundtable, key experts discussed the challenges and opportunities in developing innovative medical devices.
- Stefano Severi, Associate Professor at the Department of Electrical, Electronic, and Information Engineering “Guglielmo Marconi” of the University of Bologna, emphasized the importance of technological innovation in designing new devices.
- Massimiliano Testi, Head of the Medical Devices Sector at TÜV Rheinland Italia, addressed the challenges related to compliance.
- Gail Rodriguez, Senior Policy Advisor at the FDA (Food and Drug Administration), explained how standards can streamline device review processes.
In the afternoon, several specific technical tables addressed topics such as Device Usability (requirements and application in the pre-market phase), the use of Artificial Intelligence to demonstrate Biological Safety, the use of Regulatory Intelligence to build an effective market access strategy, how to evaluate Clinical Effectiveness for Software as a Medical Device (SaMD), validation plans, and follow-up.
The day concluded with a discussion on the impact of Post-Market Surveillance.
Bericah had the opportunity to engage with numerous entities in the Medical Devices sector, addressing topics that, while not directly relevant, enriched its internal know-how.
Through active involvement in discussions on how to develop increasingly safe and innovative devices, Bericah further strengthened its expertise.
Participation in MedGenerAction 2024 proved to be an important opportunity for exchange and growth, helping to shape the future of the medical sector.
