- CEO
- Markus Johan Emne
- Sector
- Technology services
- Industry
- Packaged software
- Address
- Malmö Sweden
- IPO Date
- Nov 7, 2018
- Business
- Hoodin AB is a Sweden-based software-as-a-service technology company that develops and provides artificial intelligence-powered regulatory governance and intelligence solutions tailored for the life sciences sector, encompassing medical technology, in vitro diagnostics, and pharmaceuticals. The company specializes in automating global regulatory monitoring, post-market surveillance, and vigilance compliance under international regulatory frameworks, including the European Union Medical Device Regulation, the In Vitro Diagnostic Regulation, and U.S. Food and Drug Administration requirements.
Hoodin AB offers its solutions through its proprietary cloud platform and specialized software modules, which include: Compliance Studio, a vertical AI regulatory governance platform that allows organizations to define, track, and maintain defensible regulatory positions across multiple products and global jurisdictions; Regulatory Signals, an automated intelligence feature that identifies relevant legislative and regulatory updates and delivers actionable insights; Post-Market Surveillance and Vigilance Reporting Modules, automated documentation tools designed to collect, filter, and structure adverse events, incident notifications, and safety literature from international databases; Data Feeds Technology, an automated data aggregation engine that monitors thousands of digital sources to replace manual surveillance workflows; and Collaboration Workspaces, an integrated feature set that enables multi-user review, task delegation, and cross-functional team coordination for regulatory audits.
The company serves medical device manufacturers, in vitro diagnostic developers, pharmaceutical companies, and specialized regulatory consulting firms across the Nordic countries, Germany, Switzerland, and the broader international market. In recent operational and corporate developments, Hoodin AB co-founded the Society for AI in Regulatory Affairs in collaboration with CertHub and MedTech Leading Voice to establish industry standards for vertical AI in regulatory environments; entered into a joint commercial partnership in Germany and Switzerland with SMeDicC for multiple Compliance Studio project deployments; completed a directed share issue raising approximately SEK 2.1 million to support sales expansion and working capital; and integrated dedicated collaboration capabilities into its Compliance Studio platform to facilitate team-based compliance workflows. Hoodin AB was founded in 2012 and is headquartered in Malmö, Sweden, with its shares publicly traded on the Nordic Growth Market under the ticker symbol HOODIN.