At Qserve, we take pride in our team of Medical Device and IVD experts. Today, we are excited to introduce you to Mike Szymonik, Senior Consultant and Regulatory Expert MD and IVD. In his role, he supports manufacturers with IVDR quiries and medical device software.
Mike joined Qserve in May 2026, bringing expertise in software as a medical device (SaMD), AI-enabled medical devices, and in vitro diagnostics (IVDs). Although he has only been with Qserve for a few months, you may already have come across him at one of our recent events. From day one, he has actively represented Qserve at industry events in China, connecting with IVD and AI professionals to share insights and discuss the evolving regulatory landscape.
Prior to Qserve, Mike led the IVDR conformity assessment service at SGS Notified Body 1639, where he oversaw the activities of a team of regulatory experts, as well as delivering regulatory assessments of technical documentation under the IVDR and MDR, with a focus on software medical devices and in vitro diagnostics. Before entering the regulatory affairs domain, he spent over a decade in IVD R&D, working on a broad range of clinical diagnostic technologies from immunoassays to molecular diagnostics, including custom instrumentation and data analytics pipelines.
Mike combines hands-on regulatory assessment experience with deep technical knowledge of diagnostic technologies and medical device software, bringing a dual perspective on both product development and conformity assessment. He has extensive experience with EU MDR/IVDR and working knowledge of global frameworks including FDA and UK requirements
One of Mike's area of focus is software and AI. He is passionate about turning cutting-edge analytical techniques into real-world healthcare solutions. He has ample experience in:
Mike uses an integrated approach based on his expertise in IVD technologies and clinical applications.
The structure of performance evaluation under IVDR (IVDR concepts and Clinical Evidence for IVD Medical Devices)
Clinical performance evaluation of IVDs - Data requirements
IVDR 2.0
We are excited to have Mike on board and look forward to the impact he will make in supporting manufacturers with IVD and AI-related challenges. Are you looking for medical device support under MDR/IVDR? Get in touch with our team to discuss how we can support your regulatory journey.