Asteron

Asteron helps European healthtech companies remove compliance blockers before hospital adoption, audits and market access. We work across two core tracks: medical devices / SaMD and health software outside MDR.

For medical-device companies, we support the path from product development to market access with MDR/IVDR, ISO 13485, IEC 62304, ISO 14971 and IEC 81001-5-1. We help teams build the required QMS, software lifecycle, risk-management and product-cybersecurity evidence, prepare for notified-body review, and close specific regulatory or security workstreams alongside existing QA/RA teams.

For health-software and clinical-AI companies outside the medical-device route, we build and operate the security and compliance foundation required by hospitals, enterprise buyers and European regulation. This includes ISO 27001, NEN 7510, ISO 27701, ISO 42001, AI Act, NIS2, CRA and related requirements.

Asteron is designed for healthtech teams that need execution, not another advisory report. We combine automation with hands-on senior expert delivery: scoping the actual requirements, preparing policies and evidence, coordinating audits, supporting customer security reviews, and keeping the system current after certification. Our projects are delivered with a defined scope, fixed price and a named senior specialist, while keeping the workload on the client team as low as possible.

The goal is simple: one accountable partner for the compliance work standing between your product and the next commercial or regulatory milestone.