- Why Us
FREE ON-DEMAND VIRTUAL SUMMIT:
August 30-September 1, 2022
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.
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