This webinar took place on July 10th. Click the button below to view it on demand!
Say goodbye to boring webinar and hello to interactivity with TEQ Talks!
Join us in this innovative approach to technical and quality talks, led by our experts. Get ready to actively participate and join the conversation, where selected attendees will have the chance to introduce themselves and ask their questions live to our experts.
Are you ready for this new and exciting way of learning?
Luisa Cabria speaker Global Vice President of Medical Device Compliance & Regulatory Affairs
Stephen Tyrpak speaker Associate VP of Medical Device Operations US & Canada
Thomas Carganico moderator
Vice President Strategic Development, Marketing & Communications / Equity Partner at PQE Group
What will I learn?
The United States FDA and European Union's MDR share many similarities when it comes to how they regulate and govern medical devices, but they also share a fair amount of differences. It is important that companies understand how to devlop regulatory pathways and quality systems that comply with both authorities if global distribution is of interest. PQE's EU and US experts will be discussing what it takes to bring a device to both of these markets. The talk will outline key considerations for comapnies who are deciding to enter one, or both markets as well as companies who are looking to expand from one to the other. The discussion will include topics such as; how to classify a device, what are the regulatory pathways and market application types, as well as the major differences between the two authorities.
