Overview

This service provides expert regulatory support for startups, SMEs, and research projects working on AI-based and digital medical technologies. Provided by SMAILE at Karolinska Institutet, the service helps navigate the complex requirements of the EU Medical Device Regulation (MDR), especially for software as a medical device (SaMD), wearable devices, and AI-powered diagnostics. Guidance includes risk classification, conformity assessments, documentation gap analysis, and strategy development.

We provide expertise and support in: • EU MDR readiness and gap analysis • Regulatory strategy for AI-based and digital devices • Documentation review for CE-marking

How can the service help you?

Whether you’re preparing for a clinical trial or a CE submission, this service helps reduce regulatory risk and accelerates your go-to-market process. It is particularly valuable for early-stage developers unfamiliar with MDR Annexes, UDI, and performance evaluations.

How will the service be delivered?

Delivered virtually, with review sessions and feedback meetings. For complex projects, hybrid support is available, including hands-on workshops at the Karolinska Institute. Timeline varies: from a 1-week consultation to a 6-week full regulatory mapping.

Additional Information

Provider Description

SMAILE supports startups and innovators through regulatory guidance for digital health and AI technologies. The team includes experts in MDR, AI Act, clinical evaluation reports (CER), and technical documentation for medical devices.

Technical Description

The service includes mapping your product against MDR Annex VIII, evaluating classification and intended use, and reviewing QMS and risk management documentation.

Service Customization

Custom modules include technical documentation audits, clinical evaluation design support, and guidance for combination products or health apps.