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FREE ON-DEMAND VIRTUAL SUMMIT:
August 30-September 1, 2022
Global MedTech Regulatory Trends True Quality Summit Series
Join us for a Tour Around the World of the Global Regulatory Landscape!
MedTech’s global regulatory landscape has changed drastically over the last decade. Policies are evolving across the globe and more programs and processes are being introduced by regulatory authorities to support further innovation.
The regulatory landscape impacts both product development activities and commercialization timelines.
In this True Quality Summit Series, we’re taking a tour around the world and diving into the state of regulations, upcoming critical events, and what you can expect in the future.
Sessions
Designing an International Regulatory Strategy: Why do so many get it wrong? | Michael Drues, PhD and Etienne Nichols
State of Swexit/Brexit | Matthias Bissig and Patricia Christine Vest
UDI - US vs EU: What You Need to Know | John Lorenc and Gary Saner
FDA Today - EUA & SaMD | Allison Komiyama, PhD and Michael Nilo
EU MDR: Are you on Pace? | Adnan Ashfaq, Michael Galliker, Laurie Rowe, and Craig Story
Adhering to and Preparing for Changing Clinical Requirements Around the Globe | Jon Ingi Bergsteinsson M.Sc., Matt Wagener, and Alethea Wieland
Regulatory & Product Development: Relationship Counseling Course | Carolyn Algar Guthrie MS RAC, Carrie Hetrick, Dylan Horvath, and Justin Matchett
QMSR Harmonization - The Good the Bad and the Ugly | Seyed Khorashahi
MDSAP Certification: Success and Failures | Danny Kroo
The Global Guide to Human Factors and Usability Engineering Regulations | Bryant Foster
Navigating APAC Regulations for Medical Device Companies | Pierre Lonchampt, Andrew See, and Andrew Wu
Insights on the MedTech Regulatory and Clinical Environment in Israel | Adi Ickowicz
Latin American Regulations - What you Don't Know | Marcelo Brisolla, Josué Garza, and Alvaro Rincon Mautnerv
Reducing Friction Between Companies and Regulatory Bodies | Simon Wieser
Making Headway Despite the Turbulence: Regulatory Requirements, Quality, and your QMS | Joanne Lebrun
Watch the Summit Series
Specifically, this summit series will cover:
- Engaging sessions around Brexit/Swexit, UDI, MDSAP, QMSR Harmonization, EU IVDR, and more!
- Learn from speakers with expertise and insights in each region — from Israel to Latin America, to APAC, to EMEA and North America.
- Discover key deadlines, updates, and dealbreakers that are necessary for you to get (and keep) your devices on the market
- Learn how to stay ahead of the ever-evolving changes and trends in the industry
- Choose your own adventure across 15 sessions, ask live questions, and get instant access to hours of on-demand recordings when the event is over
Who should attend?
- Medical Device Executives & Leadership Teams
- Quality Professionals and Management
- Regulatory Affairs Professionals and Management
- Clinical Affairs Professionals and Management
- R&D Engineers and Management
