Marika Karjalainen
Marika Karjalainen is a biochemist, doctoral researcher at the University of Helsinki, and medical-device regulatory and quality specialist with more than 20 years of experience in diagnostics, biotechnology and health technology. As an independent consultant at Aurevia, she supports companies developing software, artificial intelligence and clinical solutions for the European and US markets. Her expertise covers regulatory strategy, clinical evaluation, quality management systems, risk management, auditing and post-market activities.
Marika has previously held senior regulatory and R&D leadership roles, guiding medical devices and IVDs from development to market under European and US regulatory frameworks. Her doctoral studies further connect her regulatory work with clinical research and the evaluation of AI-assisted technologies. She is particularly interested in turning complex requirements into practical development choices—and ensuring that innovation, clinical value and compliance move forward together.
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Mind the Gap – Navigating the Regulatory Metro Map
Medical device regulations, standards and guidance documents often appear to form an overwhelming maze of overlapping, sometimes contradictory requirements. But what if we stopped looking at them as separate obligations and started seeing them as an interconnected transport network?
Welcome aboard the Regulatory Metro, where MDR, IVDR, AI Act, ISO 13485, IEC 62304 and other regulatory frameworks become routes through the medical device lifecycle. Using an interactive map inspired by Berlin's public transport network, this session explores how requirements intersect, reinforce one another and contribute to a common destination: safe, effective and compliant medical devices.
Along the journey, we will discover the major interchange stations, navigate regulatory bottlenecks and demonstrate how a single development activity can satisfy multiple requirements. Rather than treating compliance as a collection of checklists, we will explore how development processes generate evidence that serves multiple regulatory purposes.
Mind the gap, change trains when necessary, and discover how understanding the network can make even the most complicated regulatory journey surprisingly logical.