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.


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

Global Regulations Social Graphic-2
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
Register Now  

A few of the experts...

Etienne Nichols

Medical Device Guru & Community Manager,
Greenlight Guru

Simon Wieser

Project Leader and Auditor for MDR and MDSAP,

Jon headshot
Jon Ingi Bergsteinsson, M.Sc.

Founder & Director,

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