Medical Device Design & Compliance under ISO 13485 — from technical file to CE marking

Infobiotech designs electromedical devices within a certified ISO 13485 quality management system, giving companies and startups access to the medical device sector without building an in-house regulatory infrastructure.

Our support covers the full development path: drafting of the technical file, risk analysis, industrialisation, and EMC pre-compliance testing in an anechoic chamber for early verification of requirements. We guide clients through the CE marking and certification process, integrating electronic design, firmware and software development into a single, regulatory-aware workflow.

Through our long-standing partnership with Creanova — a CDMO with its own cleanroom, assembly and packaging facilities and over twenty years of medical device experience — we extend this service through to full production, acting as a single point of contact from concept to market. Clients also gain access to a consolidated network of qualified partners for medical device design and regulatory consultancy.