The United States remains one of the most influential and highly regulated markets for medical devices. Conducting a study in this jurisdiction requires a structured regulatory approach, careful planning, and operational discipline.
Through this webinar, regulatory affairs and clinical professionals will gain practical guidance on navigating US requirements and optimizing study execution. Whether you are preparing for your first US study or refining an ongoing clinical strategy, this session will provide valuable clarity.
In collaboration with Qualtech's partner, TOTAL Diversity Clinical Trial Management, we are pleased to welcome guest speakers Melynda Geurts and Tina Bland, who will share expert insights into US regulatory pathways and the operational strategies essential for successful medical device investigations.
Key Topics to Be Addressed
- ✔ US Medical Device Classification and Risk Categories
- ✔ IRB Oversight vs. IDE Requirements
- ✔ Developing a Robust Study Design
- ✔ Site Selection Strategy and Sample Size Planning
- ✔ Best Practices in Subject Recruitment and Retention
- ✔ Remote Monitoring in Medical Device Studies
Early regulatory alignment particularly in determining IDE requirements can prevent delays and reduce compliance risks. Strategic planning in site management and subject enrollment further supports efficient timelines and budget control.
This session offers practical perspectives to help your organization make informed decisions throughout the clinical study lifecycle.
Webinar Information
- ✦ Date: Thursday, March 26, 2026
- ✦ Time: 9:00 AM (GMT+8)
- ✦ Speaker:
✦ Melynda Geurts, MS (Chief Operating Officer at TOTAL Diversity Clinical Trial Management with 20+ years of leadership experience in clinical trial operations, patient recruitment, enrollment strategy, and global clinical execution in the US market.)
✦ Tina Bland, PhD (Clinical research leader with 20+ years of experience in pharmaceutical and CRO environments, specializing in clinical operations , protocol development, health authority submissions including FDA, EMA, and TGA, and full trial lifecycle management.)
- ✦ Registration: https://forms.gle/4FrvXdcuhec4kNcPA
Participation is complimentary, but registration is required. Attendees are encouraged to submit questions in advance to ensure relevant regulatory and operational topics are addressed during the live Q&A session.
We look forward to welcoming you to this informative webinar.
