MedReg 2023 - Annual Medical Device Regulatory Confex

Step into the realm of regulatory excellence at MedReg 2023, the Annual Medical Devices Regulatory Confex that will revolutionize your understanding of medical device regulations. Get ready for a three-day virtual extravaganza where the most essential updates, traditional foundations, and cutting-edge advancements across the US FDA and EU MDR will be brought to your screen. From directors and VPs to managers, associates, and executives, this conference is tailor-made for professionals at every seniority level.

Why should you make MedReg 2023 a priority on your virtual event calendar? Let us paint a compelling picture. Imagine a world where medical device regulations are disregarded—a world where patient safety is compromised. The consequences of non-compliance are severe, but fear not! By attending MedReg 2023, you become an empowered superhero armed with the knowledge and strategies to ensure your organization thrives in the regulatory landscape.

Envision yourself virtually surrounded by the industry's luminaries and visionaries, all in one dynamic online platform. Our carefully curated agenda covers over 15 essential subjects delivered by world-renowned experts, ensuring you gain a comprehensive understanding of the ever-evolving regulatory landscape. Prepare to absorb insights, ask burning questions, and engage in stimulating discussions with like-minded professionals from around the globe.

But let's not forget the perks of attending a virtual conference. MedReg 2023 goes beyond mere learning—it's an experience designed to excite, inspire, and energize your regulatory spirit. Picture yourself comfortably seated, sipping a beverage of your choice, as you engage in interactive sessions, virtual networking opportunities, and collaborative activities. This is where connections are forged, ideas are ignited, and innovation takes flight—all from the comfort of your own space.

And the benefits don't end there. MedReg 2023 offers you not only knowledge but also actionable takeaways to revolutionize your approach to regulatory compliance. Gain expert guidance on navigating the complexities of US FDA and EU MDR regulations, discover strategies to streamline compliance processes in the virtual world, and position yourself as a regulatory trailblazer within your organization.

AGENDA:

Day 1‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Sep 25‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ US Eastern Time: 9 AM to 4 PM ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Central Europe Time: 3 PM to 10 PM
	09.00 AM - 10.15 AM		EU MDR Implementation and Transitioning 🎤 KELLY THOMAS
	10.15 AM - 11.30 AM		Technical Documents (DHF, DMR, DHR, Technical Files & Design Dossier) 🎤 JOHN E. LINCOLN
	11.30 AM - 12.45 PM		Post-Market Surveillance Activities 🎤 MEREDITH CRABTREE
	12.45 PM - 01.00 PM		Lunch
	01.00 PM - 02.15 PM		Impact Assessments for Supplier Change Notices 🎤 ALAN M. GOLDEN
	02.15 PM - 03.30 PM		Device Submission Requirements (510k, PMA, DeNovo) 🎤 EDWIN WALDBUSSER

Day 2‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Sep 26 ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ US Eastern Time: 9 AM to 4 PM ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Central Europe Time: 3 PM to 10 PM
	09.00 AM - 10.15 AM		21 CFR Part 11 Conformance for Medical Devices 🎤 CAROYLN TROIANO
	10.15 AM - 11.30 AM		Medical Device Labelling and UDI Requirements 🎤 KELLY THOMAS
	11.30 AM - 12.45 PM		Convergence of MDSAP, ISO 13485 & 21 CFR 820 Quality Systems 🎤 CHARLES H. PAUL
	12.45 PM - 01.00 PM		Lunch
	01.00 PM - 02.15 PM		Complaint Handling and Adverse Event Reporting 🎤 SUSANNE MANZ
	02.15 PM - 03.30 PM		ISO 14971 Risk Management for Medical Devices 🎤 EDWIN WALDBUSSER

Day 3 ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Sep 27 ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ US Eastern Time: 9 AM to 4 PM ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Central Europe Time: 3 PM to 10 PM
	09.00 AM - 10.15 AM		MD Cybersecurity and SaMD 🎤 CAROYLN TROIANO
	10.15 AM - 11.30 AM		CE Marking in the EU – Latest Regulations 🎤 CHARLES H. PAUL
	11.30 AM - 12.45 PM		4 cGMP Elements per QSIT: Management Responsibility, Design Control, CAPA, and P&PC 🎤 JOHN E. LINCOLN
	12.45 PM - 01.00 PM		Lunch
	01.00 PM - 02.15 PM		FDA Inspection Preparedness 🎤 ALAN M. GOLDEN
	02.15 PM - 03.30 PM		Artificial Intelligence/Machine Learning Regulations in Medical Devices 🎤 JOSÉ I. MORA