Galen Webinar Series: Regulatory and Clinical Considerations for SaMD

KEY TAKEAWAYS:  

• What does the regulatory pathway look like for SaMD? 
• What are some common mistakes that companies make and how to avoid them? 
• How should you do clinical validation and testing for SaMD  

SPEAKERS:   Isabella Schmitt, RAC is the Director of Regulatory Affairs at Proxima Clinical Research, Inc., a contract research organization focusing on assisting emerging medical device and biotech companies in regulatory, quality, and clinical development. At Proxima, Isabella is responsible for overseeing over 100+ medical device and pharma projects. Prior to joining Proxima, Isabella served as the Senior Regulatory and Quality Manager for two medical device companies, where she outlined the regulatory strategy and put together design controls and quality documentation. As the Director of CMC and Quality at a biopharmaceutical company, she oversaw all product development and ensured CMC regulatory strategy was sufficient for filings in the US and Europe.   

Karandeep Singh Badwal is an independent Quality & Regulatory consultant specializing within SaMD and AI medical devices who shares his passion for MedTech via bite sized content on Linkedin, a Podcast (The MedTech Podcast) and his YouTube Channel (QRA Medical).