DUBLIN, Aug. 15, 2023 /PRNewswire/ — The “MedReg 2023 – Annual Medical Device Regulatory Confex” training has been added to ResearchAndMarkets.com’s offering.
Step into the realm of regulatory excellence at MedReg 2023, the Annual Medical Devices Regulatory Confex that promises to revolutionize attendees’ understanding of medical device regulations.
Attendees can anticipate a three-day virtual extravaganza where the conference will present the most crucial updates, traditional foundations, and cutting-edge advancements across the US FDA and EU MDR. Professionals at every seniority level, ranging from directors and VPs to managers, associates, and executives, will find tailored content to suit their needs.
Why should attendees prioritize MedReg 2023 on their virtual event calendar? A compelling picture is painted by envisioning a world where medical device regulations are overlooked – a world that compromises patient safety. However, attendees can rest assured that by participating in MedReg 2023, they will emerge as empowered superheroes equipped with knowledge and strategies that will enable their organizations to thrive in the intricate regulatory landscape.
Attendees can visualize themselves being virtually surrounded by industry luminaries and visionaries, all converging on a dynamic online platform. The meticulously curated agenda spans over 15 essential subjects delivered by globally recognized experts, ensuring a comprehensive grasp of the ever-evolving regulatory landscape. The event promises opportunities to absorb insights, pose burning questions, and partake in engaging discussions with fellow professionals from around the world.
Moreover, the advantages of attending a virtual conference should not be overlooked. MedReg 2023 transcends traditional learning, offering an experience designed to excite, inspire, and invigorate attendees’ regulatory spirit. Imagine comfortably seated, sipping on a preferred beverage, while engaging in interactive sessions, virtual networking, and collaborative activities. This setting fosters connections, sparks ideas, and fuels innovation, all within the comfort of one’s own space.
However, the benefits extend beyond the conference duration. MedReg 2023 offers attendees actionable takeaways that can revolutionize their approach to regulatory compliance. Expert guidance will navigate the complexities of US FDA and EU MDR regulations, revealing strategies to streamline compliance processes in the virtual realm. As attendees position themselves as regulatory trailblazers within their organizations, they will witness not only knowledge but also transformative impact.
Key Topics Covered:
Day 1 – Sep 25 US Eastern Time: 10 AM to 4 PM
- 09.00 AM – 10.15 AM – EU MDR Implementation and Transitioning
- 10.15 AM – 11.30 AM – Technical Documents (DHF, DMR, DHR, Technical Files & Design Dossier)
- 11.30 AM – 12.45 PM – Post-Market Surveillance Activities
- 12.45 PM – 01.00 PM – Lunch
- 01.00 PM – 02.15 PM – Impact Assessments for Supplier Change Notices
- 02.15 PM – 03.30 PM – Device Submission Requirements (510k, PMA, DeNovo)
Day 2 – Sep 26 US Eastern Time: 10 AM to 4 PM
- 09.00 AM – 10.15 AM – 21 CFR Part 11 Conformance for Medical Devices
- 10.15 AM – 11.30 AM – Medical Device Labelling and UDI Requirements
- 11.30 AM – 12.45 PM – Convergence of MDSAP, ISO 13485 & 21 CFR 820 Quality Systems
- 12.45 PM – 01.00 PM – Lunch
- 01.00 PM – 02.15 PM – Complaint Handling and Adverse Event Reporting
- 02.15 PM – 03.30 PM – ISO 14971 Risk Management for Medical Devices
Day 3 – Sep 27? US Eastern Time: 10 AM to 4 PM
- 09.00 AM – 10.15 AM – MD Cybersecurity and SaMD
- 10.15 AM – 11.30 AM – CE Marking in the EU – Latest Regulations
- 11.30 AM – 12.45 PM – 4 cGMP Elements per QSIT: Management Responsibility, Design Control, CAPA, and P&PC
- 12.45 PM – 01.00 PM – Lunch
- 01.00 PM – 02.15 PM – FDA Inspection Preparedness
- 02.15 PM – 03.30 PM – Artificial Intelligence/Machine Learning Regulations in Medical Devices
Speakers
- Alan M. Golden
- Caroyln Troiano
- Charles H. Paul
- Edwin Waldbusser
- John E. Lincoln
- Jose I. Mora
- Kelly Thomas
- Meredith Crabtree
- Susanne Manz
For more information about this training visit https://www.researchandmarkets.com/r/94zifp
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SOURCE Research and Markets
