Qualtech invites you to join our free webinar on Thursday, November 26, 2026, focusing on Clinical Evidence Requirements and the Clinical Investigation Landscape to Access the European Market.
During this session, our invited guest speaker from Spain-based Contract Research Organization (CRO) Iberania will share practical insights into the EU MDR clinical evidence requirements and how to plan and conduct clinical investigations in Europe.
This subject is of particular importance, since demonstrating sufficient clinical evidence is a fundamental requirement for medical device manufacturers seeking to obtain and maintain market access in the European Union. Understanding the applicable requirements, identifying appropriate sources of clinical evidence, and determining whether a clinical investigation is necessary are therefore essential steps in developing an effective regulatory strategy.
Key Discussion Topics
- › Clinical Evidence Requirements under the EU MDR: Clinical evaluation, sources of clinical evidence and equivalence.
- › Clinical Investigation Requirements and Planning: When a clinical investigation is needed, key regulatory requirements and study design.
- › Conducting Clinical Investigations in Europe: Site selection, patient recruitment and practical challenges.
- › Key Takeaways and Recommendations: Practical considerations for navigating clinical evidence and clinical investigations for EU market access.
- › Live Q&A Session: Bring your questions! Our guest speaker will address relevant topics during the dedicated Q&A session.
Webinar Details
- › Date: Thursday, 26 November 2026
- › Time: 4:00 PM (GMT+8) | 9:00 AM (CET)
- › Speaker: Qualtech’s invited guest speaker from Spain-based CRO company Iberania.
- › Registration Link: https://us02web.zoom.us/webinar/register/WN_1M5zVzcrTdGvuktZTZLSxQ
Meet our speakers
Beatriz Rodriguez Grande, PhD
Manager CRO Operations - Regulatory, Iberania
- 15 years of experience in Regulatory, Medical Affairs and Academic Research.
- Expertise in EU MDR, clinical evaluation, and medical device regulatory strategy.
Raquel Sofia Cordeiro, PhD
Manager CRO Operations - Clinical, Iberania
- 13+ years of experience in pre-clinical and clinical research, specializing in medical devices.
- Expertise in clinical study design, clinical development strategy and clinical investigation management.
When registering, participants will also have the opportunity to submit their regulatory questions in advance, allowing our guest speakers to address relevant topics during the live Q&A session of the webinar.
We look forward to welcoming you to this free and informative session!
For questions regarding the webinar or registration, please contact globalra@qualtechs.com.
