Case Study
Medical Devices

MVision AI Oy: Streamlining EU MDR, ISO 13485 and MDSAP with BSI

The People

MVision AI Oy is a Finnish SaMD innovator who develops AI‑powered Software as a Medical Device

In particular, they deliver AI cloud-based solutions, for precision radiotherapy workflows, supporting planning and delivery for clinicians globally.

The Challenge

MVision AI Oy needed timely EU MDR conformity for its first device during the MDD to MDR transition

Operating within the MDD to MDR transition window, MVision AI Oy faced compressed timelines and heightened scrutiny for AI‑enabled radiotherapy SaMD.

Separate Notified Bodies for EU MDR, ISO 13485, and MDSAP multiplied audit touchpoints alongside significant internal resources adjustment, which increased risks, costs, and introduced potential delays.

Time was being invested in document controls, reconciling evidence, responding to queries, and sequencing activities. This increased coordination burdens across teams, slowing decisions and jeopardizing time to market for innovations needed by clinicians and patients globally.

As launch dates for their product were under threat, MVision AI Oy found their scale‑up plans to enter new regions needed potential revisions and adjustments to enable delivery with confidence.

The Solution

Transferring to a single Notified Body, such as BSI, allowed one touch point and consistent oversight

It also simplified and streamlined the process as well as avoiding multiple reviews.

The dedicated Scheme Manager who co-ordinated the Conformity Assessment Process, acted as a single point of contact. This maintained momentum during the certification process.

Structured guidance improved evidence readiness and streamlined submissions. Running certifications in parallel shortened review cycles, and reduced uncertainty, enabling more predictable route to market aligned to MVision AI Oy’s expansion goals.