Keeping Pace with Regulation: Our Experts at the MDR / IVDR Quality Days
In the fast-evolving world of medical devices, continuous education is essential. That is why our team participated in the prestigious professional conference DNY KVALITY MDR / IVDR, organized by the certification body 3EC International.
The intensive three-day program focused on key topics currently shaping the medical device industry. Our experts explored several important areas, including:
- Recent regulatory updates to MDR and IVDR, including transitional provisions
- Clinical evaluation and Post-Market Surveillance (PMS)
- Cybersecurity of medical devices – a critical issue for modern healthcare technologies
- Risk management and biological safety evaluation
- Optimization of certification processes to support faster market access
Through direct discussions with industry specialists and representatives of notified bodies, we gained valuable insights that help us navigate regulatory compliance more efficiently and ensure our partners meet the strictest European standards.
We continue to invest in the expertise of our team so we can remain a reliable and well-informed partner for our customers and collaborators.