SMEDTEC OÜ is the research and innovation arm of SMEDTEC, focused on building the next generation of regulatory intelligence tools for the global medical device and IVD ecosystem. Our mission is simple: to make regulatory science faster, clearer, and more grounded in data.

We explore how modern technologies—AI, machine learning, natural-language processing, large-scale data extraction, and advanced analytics—can be applied to the complex world of regulatory frameworks. From 21 CFR to EU MDR, from product codes to predicate relationships, we are committed to understanding how information flows through regulatory systems and how those systems can be made more navigable for innovators, clinicians, manufacturers, and regulators themselves.

SMEDTEC OÜ operates at the intersection of regulatory science, human factors, data engineering, and computational analysis, with a focus on:

• Mapping regulatory pathways with precision
• Building intelligent tools that interpret regulations, classifications, and product families
• Creating structured datasets from unstructured regulatory text
• Developing new methods for predicate identification and device similarity scoring
• Enhancing transparency around risk, safety, and performance data
• Supporting public and private organisations seeking smarter regulatory workflows

We believe regulatory work should be evidence-driven, automated where safe, and augmented by intelligence—not constrained by outdated processes or fragmented information sources.

If you are interested in collaborative research, co-development, API access, or exploring new approaches to regulatory intelligence, we would love to speak with you.