Introduction to FDA Regulatory Process for EU Companies

Speaker Paige Sutton-Smith

Date May 20th, 2025, Online

Duration 3 hours | 9:00 – 12:00 AM US Eastern Daylight Time, 3:00 – 6:00 PM Central Europe Summer Time

Virtual A recording will be available to registered participants, in case they are not able to attend all the live sessions.

For more information or questions, please contact: training@veranex.com

About the Speaker

Paige is a quality management and regulatory professional with 13 years in the medical device industry. Her expertise includes regulatory strategy, product design and development, process validations, V&V, QMS deployment, and auditing to FDA 21 CFR 820 / ISO 13485. She is experienced with complex invasive and implantable devices. Paige assists clients with product design and development of Class II and Class III medical devices, including regulatory submissions and complex process control and supplier strategies. She holds a RAC (Regulatory Affairs Certification) – Devices and is a Certified Quality Engineer and Certified Six Sigma Black Belt.

TRAINING CONTENT  

By attending this training, you will receive an in-depth discussion of the following topics: 

• FDA device classification process 

• Exempt devices 

• 510(k) Premarket Notification pathway 

• De Novo pathway 

• Premarket Approval (PMA) pathway 

• Humanitarian Device Exemptions (HDE) 

The following topics will also be included in the training: 

• Breakthrough Device Program 

• Safer Technologies Program  

• Q-Submissions 

• Small Business Designation 

• 513(g) Request for Information 

TO WHOM IT IS ADDRESSED

• R&D, Engineering, and Design and Development professionals 

• Quality and Regulatory professionals 

• Start-up companies looking to understand US marketing options 

• Medical device professionals in the EU looking to expand to the US market 

PRICE  

EUR 415 including course material and certificate