Specculo

At Specculo, we provide efficient, high-quality regulatory affairs and quality assurance services to medical device manufacturers, importers, and distributors operating in the EU and UK. Our goal is to make compliance straightforward, so you can focus on developing safe, effective products. Representation - EU Authorised Representative (EC-REP)- UK Responsible Person (UK RP). We act as your official representative, ensuring that your regulatory responsibilities in the EU and UK are fully met. Regulatory Affairs Consulting - Technical documentation and gap assessments- Device classification and qualification- Regulatory strategy and submissions- EUDAMED registration support- Training services. Quality Assurance Consulting - QMS implementation and maintenance (ISO 13485:2016)- Internal and supplier audits. Whether you are entering the EU or UK market, or strengthening ongoing compliance, Specculo offers clear, practical support at every stage.