Accelerate your clinical algorithm/prediction model to market with Evidencio’s CE-Certification Roadmap

As a developer or IP-owner of a clinical algorithm, you partner with Evidencio for the full regulatory journey — from conception to CE-marked medical-device software. We act as your Legal Manufacturer, leveraging our ISO 13485-compliant quality system and ISO 27001/NEN 7510-compliant cloud-enabled infrastructure to streamline your pathway.

With us you receive:

• A pre-assessment that clarifies classification, intended use, risk class and scope — starting at a fixed price.

• Technical-file development, leveraging a proven QMS and infrastructure to reduce cost and risk.

• A full CE-certification process including Notified Body engagement, clinical evidence generation and conformity assessment — all managed for you.

• After CE-certification, you can market and distribute your algorithm yourself, jointly, or use Evidencio’s international network for deployment.

Why choose Evidencio?

• Significantly reduced cost and lead-time thanks to reuse of infrastructure and QMS.

• Full regulatory compliance with ISO 13485, ISO 27001 and NEN7510 — so security, data protection and device regulation are already built-in.

• A single partner handling both the technical deployment and regulatory certification, enabling you to focus on your algorithm and clinical value.

Let Evidencio carry the regulatory burden — so your algorithm becomes a CE-certified, market-ready medical device tool.