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Ardeevo

Ardeevo is an AI-native regulatory service for MedTech manufacturers entering the European market. We support medical device and in vitro diagnostic companies with the documentation required by the MDR (EU 2017/745) and the IVDR (EU 2017/746): support in drafting technical and system documentation, reviewed by experts, at a fixed cost and on defined timelines, with milestone-based payments. The work follows three steps: AI drafting by Clark, our AI agent; validation with an expert in the loop; expert review with mandatory approval. No document is delivered without an expert's sign-off. Our services: Ardeevo Regulatory Compass — device qualification, classification and regulatory pathway Ardeevo Technical File Readiness — technical documentation, evidence, consistency of the technical file Ardeevo Lifecycle Compliance — monitoring, impact of changes, post-market surveillance Services for the quality management system (ISO 13485) We work first with manufacturers of medium-risk devices: European startups and SMEs seeking their first CE marking, and non-EU companies entering the European market. The technical documentation remains drawn up and controlled by the manufacturer; conformity assessment is the responsibility of the Notified Body. Our mission: healthcare innovation must reach patients, not stop at regulation.

Complaion

Complaion helps SMEs implement, maintain, and get real value from ISO certifications. We combine a software platform that automates up to 80% of the process with a certified ISO Lead Auditor who takes care of the remaining 20%. We guarantee speed and a streamlined, digital, and cost-effective approach. We have supported 350+ companies in obtaining and maintaining ISO 9001, ISO 14001, ISO 45001, ISO 27001, ISO 27017, ISO 27018, and many other certification schemes. To learn more, visit our website.

FlexyGrid

FlexyGrid allows you to monitor and optimize your consumption ⚡ You can also create and manage a renewables energy community in all steps, from managing optimum transactions of production, consumption and accumulation. Achieving economical benefit for all actors of the energy system, spanning across residential/industrial users and electric mobility.