Specculo Limited

Specculo is a boutique EU medical device regulatory consulting firm supporting MedTech innovators across the full product lifecycle. Founded and led by senior regulatory affairs and quality professionals with over a decade of RA/QA experience, we help startups and established manufacturers place safe, compliant products on the European market. Our expertise spans EU MDR and IVDR, the AI Act, and related product legislation including the EMC, Low Voltage and Radio Equipment Directives. We act as EU Authorised Representative and Regulatory Importer, build and remediate technical documentation, implement ISO 13485 quality management systems, develop regulatory strategy and roadmaps, support EUDAMED registration and post-market surveillance, and deliver hands-on training. Operating from Malta and London, we work as an embedded partner rather than a distant agency, giving clients direct access to senior expertise from day one. We are known for clear, practical guidance that demystifies complex regulation, and for being honest about what is hard while solving it collaboratively. Our mission is to make EU regulatory compliance accessible, predictable and achievable for innovative medical technology companies entering and scaling within the European market.