MedTech Regulatory Intelligence Conference
March 25 2026 • Qserve Arnhem Headquarters
Join DistillerSR and Qserve for the MedTech Regulatory Intelligence Conference on 25 March 2026. This in-person gathering will convene regulatory professionals, industry experts, and MedTech innovators to examine current regulatory challenges and strategic developments shaping the medical device sector, including the increasing role of data-driven insights and AI.
Attendees will gain insights from Notified Body expert overviews, learn from real-world customer panels, and explore how the responsible and compliant use of AI within regulated MedTech environments can have a positive impact on regulatory submissions and time-to-market. The conference is designed to be a valuable opportunity to network and exchange knowledge with industry peers, deepen regulatory understanding, and connect with experts driving strategy and innovation within the MedTech industry.
Agenda – March 25 2026
Registration + Networking Lunch
Notified Body Roundtable: EU-MDR Proposed Changes and Expected Impact
- Understand the Foundations of a CER: Gain a clear understanding of the purpose and regulatory context of the Clinical Evaluation Report within the MDR framework.
- Establishing Equivalence: Master the process of claiming equivalence to other devices, including the critical information and justification required to demonstrate safety & performance.
- Conducting Risk-Benefit Assessment: Master the methodology for conducting a thorough benefit-risk assessment, a crucial component of the CER.
- Leveraging Clinical Data: Explore various sources of clinical data, including literature reviews, literature search strategies, and manufacturer-generated data. Understand the Notified Body’s expectations for conducting and documenting thorough literature searches.
- Documenting Clinical Investigations: Gain insights into documenting clinical investigations, including the necessary supporting documentation and understanding the different perspectives of Notified Bodies and Competent Authorities.
- Considering Post-Market Activities: Understand the link between the CER and post-market clinical follow-up (PMCF) activities and how ongoing data collection informs CER updates.
Speakers
Bassil Akra, CEO at AKRA Team
Lucy Stone, Principal Clinical Evaluation Specialist at BSI
Chip Couch, Learning Specialist at DistillerSR
1:45 PM – 2:45 PM
How Are Regulatory Teams Leveraging AI
- Understand the existing challenges and bottlenecks in MedTech regulatory submissions, time to market, and innovation processes.
- Learn how AI and automation can expedite the preparation, review, and submission of regulatory documents, potentially leading to faster approvals.
- Explore the potential challenges, risks, and ethical considerations associated with using AI in regulatory and innovation processes, such as data bias, security, and the need for human oversight.
Speakers
Angelina Lisandrelli, Director of Regulatory and Quality at RespirTech, a Philips company
Emily Metcalfe, Director, Scientific Communications at Boston Scientific
Julie Pritchard-Hedtke, President at AVIO Medtech Consulting
Peter O’Blenis, CEO at DistillerSR
2:45 PM – 3:15 PM
Coffee Break
3:15 PM – 4:15 PM
LLMs, Agentic AI, Assistants: Real Applications and Limitations in the Regulatory Submissions Context
- Understand current interpretations, expectations, and best practices directly from Notified Body representatives regarding critical aspects of the EU MDR and IVDR.
- Learn about the recurring challenges faced by manufacturers during the conformity assessment process and gain insights into how to proactively address them.
- Participate in a direct dialogue with Notified Body experts, ask specific questions relevant to your organization, and connect with peers navigating the EU regulatory landscape.
Speakers
Bassil Akra, CEO at AKRA Team
Lucy Stone, Principal Clinical Evaluation Specialist at BSI
Julien Senac, Senior Director, Medical and Health Services Americas at TÜV SÜD
Azam Korshidi, Technical File Reviewer, IVD at DEKRA
4:15 PM – 5:15 PM
Closing Remarks and Final Q&A
- Discover how SciBite uses standardized ontologies to automatically enrich unstructured text with consistent, machine-readable concepts, providing deeper contextual understanding for your evidence data.
- Learn how DistillerSR integrates with ontologically enriched data to streamline the systematic review process, improving search precision, filtering, and overall workflow efficiency.
- Understand how the combined power of SciBite and DistillerSR, leveraging standardized ontologies, enhances data accuracy, consistency, and facilitates the discovery of deeper insights from your evidence.
Speakers
Tom Woodcock, Technical Sales Manager at SciBite by Elsevier
Chris Wright, EVP of Operations at DistillerSR
5:15 PM – 6:15 PM
Networking Drinks
Qserve Group: HQ and visiting address
Arnhems Business Park
Utrechtseweg 310 – Building B42
6812 AR Arnhem
The Netherlands
© Copyright DistillerSR Inc. 2025. All Rights Reserved.
© Copyright DistillerSR Inc. 2025. All Rights Reserved.