"Medical Device Compliance 360° – Navigating Ever-Changing Regulations"
The regulatory framework for medical devices is evolving rapidly, bringing new compliance challenges for manufacturers and healthcare professionals. From MDR updates to shifting biocompatibility requirements, AI Act impacting SaMD, and material restrictions impacting (e.g. DEHP-free) blood bags as a primary packaging for ATMPs. Ensuring compliance while maintaining product safety and performance is more complex than ever.
Join our expert-led webinar to gain a 360° compliance overview and learn how to navigate the latest regulatory shifts with confidence.
Who Should Attend?
- Medical Device Manufacturers navigating MDR, notified body approvals, and new material restrictions.
- Healthcare Professionals in Transfusion Medicine impacted by regulatory changes in blood component storage and processing.
- ATMP & Cell Therapy Experts working with cryopreserved and blood-derived therapies facing new compliance challenges.
Key Topics We’ll Cover:
- MDR & Beyond – What’s new, and how it affects medical device certification.
- AI in Medical Devices – The impact of the EU AI Act on compliance & risk assessment.
- Material Changes & Compliance – REACH, SVHC, and the implications of plasticizer restrictions.
- Shifting Biocompatibility Assessment Requirements – How evolving ISO 10993 standards impact testing, validation and regulatory expectations.
- Risk Management & Usability – Meeting MDR & ISO 14971 safety requirements.
- ATMPs & Blood Bag Regulations – The latest requirements for cellular therapy packaging & DMSO compatibility.
- Future Trends & Market Readiness – What’s next in EU regulations, and how to stay ahead.
Stay ahead of regulatory challenges!
Our webinar will take place on the following three dates. Please select your preferred date here:
April 1st, 2025 – 11:00-12:00 am (UTC+2)
April 3rd, 2025 – 11:00-12:00 am (UTC+2)
April 8th, 2025 – 11:00-12:00 am (UTC+2)