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.
Current AI Applications in Medical Device and IVD Regulatory Submissions: Which AI technologies are being deployed today in regulatory processes, from clinical literature review and clinical evaluation to technical documentation assembly and post-market clinical follow-up? Distinguish between hype and practical, validated applications for regulatory submissions that pass the auditability, reproducibility, and defensibility.
Agenda – March 25 2026
Registration + Networking Lunch
Notified Body Roundtable: Navigating the Next Wave of EU-MDR Proposed Amendments
- Redefining “Sufficient Evidence”: Direct guidance on the proposed shift toward more risk-proportional clinical data requirements and what this means for legacy and innovative devices.
- Streamlining Conformity Assessment: Practical insights into how the proposed changes aim to reduce repetitive administrative burdens without compromising the integrity of the certification process.
- PSUR Frequency and Post-Market Efficiency: Understanding the proposed “risk-based” frequency for PSUR updates and how to realign surveillance teams while reducing manual reporting cycles.
- Expected Adoption Timelines: Break down the expected legislative milestones for 2026 and 2027, including expected transition periods and how manufacturers should plan the alignment of technical documentation.
Speakers:
Stefano Riva, Principal Technical/Clinical Specialist & Scheme Manager (Active Devices) at BSI Group
Natascha Cuper, Clinical and Technical Expert at Kiwa
Shruti Gangwak, Regulatory Lead at BSI
Nunung Nur Rahmah, Head of Internal Clinical Team at DEKRA
René Schings, BA Lead QMS & Audit, Principal Consultant at Qserve Group
1:45 PM – 2:45 PM
Defensible, Scalable, Fast: A Practical AI Framework for Regulatory Submissions in Medical Devices
- Why Data Governance Comes First: For regulatory teams looking to leverage AI, the promise of faster submissions and reduced time to market is only as strong as the data that powers it. AI models are inherently dependent on the quality, consistency, and integrity of their source data — and in a regulatory context, where every output may be scrutinized by a health authority, the stakes of poor data governance are particularly high.Understand how strong data governance frameworks and data quality standards are foundational to deploying AI that produces reliable, submission-ready outputs.
- Understand Proven Implementation Approaches: Discover practical frameworks for piloting and scaling AI solutions in regulatory environments, including how to start with quick wins, build internal capabilities, and integrate AI tools with existing quality management systems. Explore how scalable and reproducible AI architectures—grounded in clean, well-governed data—enable consistent performance across submission types and geographies while maintaining validation and compliance throughout deployment.
- Navigate Quality and Compliance While Accelerating Timelines: Explore strategies for ensuring AI-enabled processes meet regulatory expectations, including approaches to validation, documentation, audit trails, and human oversight. Learn how data quality issues—such as incomplete, inconsistent, or poorly structured source data—can introduce compliance risk, and how defensible AI workflows with clear lineage, traceability, and version control help regulatory teams maintain credibility with agencies while accelerating cycle times.
- Identify High-Impact AI Use Cases for Time Reduction: From initial concept through post-market surveillance, the medical device lifecycle is filled with documentation-heavy, research-intensive, and iterative processes that are ripe for AI-assisted acceleration. However, not all use cases deliver equal value — identifying where AI can have the greatest impact requires a clear understanding of where time is lost, where data is abundant, and where the regulatory risk of automation is manageable.
Speakers:
Sepanta Fazaeli, PhD, Head of AI Solutions – Life Sciences at Transperfect
Gert Bos, PhD, FRAPS, Chief Scientific Officer at Qserve Group
Michael Konings, Global Head of Regulatory Affairs, Image-Guided Therapy Systems at Philips
2:45 PM – 3:15 PM
Coffee Break
3:15 PM – 3:35 PM
Bridging Evidence Silos: Where AI Meets Regulatory Reality
- Understand where AI adoption in MedTech actually stands — and why most organisations are stuck Benchmark your organisation against current industry data on GenAI deployment, value realisation, and the six most common barriers holding the sector back — from strategy gaps and pilot purgatory to regulatory uncertainty under the converging demands of MDR and the EU AI Act.
- Map the evidence lifecycle and identify where duplication is costing you mostExplore how the same clinical evidence is systematically re-reviewed across CERs, PMCF, PSURs, HTA, and safety submissions — and understand why a platform-based approach to evidence management is a prerequisite for AI to deliver measurable value at scale.
- Choose the right AI approach for your regulatory context Compare the risk, control, and regulatory readiness profiles of manual processes, point solutions, general-purpose LLMs, and purpose-built platforms — and understand what the EU AI Act’s high-risk classification, audit trail requirements, and human oversight mandates mean for how you deploy AI in clinical evidence workflows today.
- Build a practical roadmap from pilot to enterprise evidence system Apply a proven Foundation → Pilot → Enterprise framework to your organization’s evidence workflows — including how to identify the right starting point, measure early wins, secure cross-functional buy-in, and scale toward a single source of truth for evidence reuse across regulatory, clinical, medical affairs, and market access functions.
Speakers:
Hans-Peter Meulekamp, Sales Director EMEA at DistillerSR
3:35 PM – 4:15 PM
CEO Fireside Chat: Are Your Submissions AI-Ready — Or Already Behind?
- Current AI Applications in Medical Device and IVD Regulatory Submissions: Which AI technologies are being deployed today in regulatory processes, from clinical literature review and clinical evaluation to technical documentation assembly and post-market clinical follow-up? Distinguish between hype and practical, validated applications for regulatory submissions that pass the auditability, reproducibility, and defensibility.
- Medical Device Regulatory and Compliance Landscape: Explore how the FDA, notified bodies, and competent authorities are responding to AI-enabled submissions, including emerging guidance under MDR/IVDR, validation expectations for AI tools, and strategies for maintaining compliance and quality management system requirements when leveraging AI in regulated documentation.
- Organizational Readiness and Change Management Strategies: Identify the key organizational capabilities and change management considerations to successfully integrate AI technologies into medical device and IVD regulatory submission workflows while taking into account data governance and data harmonization best practices.
- The Future of Medical Device Regulatory Affairs: Discuss upcoming trends and shifts in how regulatory submissions will evolve, including notified body and agency expectations, technology convergence with Software as a Medical Device (SaMD) considerations, and strategic decisions device and IVD manufacturers should be making now to remain competitive in an AI-enabled regulatory landscape.
Speakers:
Peter O’Blenis, CEO at DistillerSR
Jan van Lochem, CEO at Qserve Group
4:15 PM – 5:15 PM
Closing Remarks and Final Q&A
5:15 PM – 6:15 PM
Networking Drinks
Speakers
Sepanta Fazaeli, PhD
Head of AI Solutions – Life Sciences at Transperfect
Gert Bos, PhD, FRAPS
Chief Scientific Officer at Qserve Group
Michael Konings
Global Head of Regulatory Affairs, Image-Guided Therapy Systems at Philips
Stefano Riva
Principal Technical/Clinical Specialist & Scheme Manager (Active Devices) at BSI Group
Natascha Cuper
Clinical and Technical Expert at Kiwa
Shruti Gangwal
Regulatory Lead at BSI
Nunung Nur Rahmah
Head of Internal Clinical Team at DEKRA
René Schings
BA Lead QMS & Audit, Principal Consultant at Qserve Group
Jan van Lochem
CEO at Qserve Group
Peter O'Blenis
CEO at DistillerSR
Qserve Group: HQ and visiting address
Arnhems Business Park
Utrechtseweg 310 – Building B42
6812 AR Arnhem
The Netherlands
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