FabolaEvidence and validation

Evidence and validation for medical devices and IVDs

More validation is not automatically better validation.

The question is whether the evidence supports what the product is for and what is said about it. Fabola translates intended purpose, claims, technology and risk into an evidence strategy: what needs to be demonstrated, with what data, and to what level of confidence.

A scientist pipetting samples into a 96-well plate

What the evidence has to support

Four questions decide whether evidence is sufficient. Most evidence problems trace back to one of them.

The intended purpose

Evidence is judged against what the device is intended to do, for whom and in what setting. A vague intended purpose makes it impossible to say when the evidence is enough.

The claims

Every clinical or performance claim in the labelling, instructions and marketing needs evidence behind it. Narrowing a claim can be cheaper than generating evidence for it.

The population

Data from one population does not automatically carry over to another. The evidence needs to represent the patients, users and conditions the product is intended for.

The regulatory pathway

Classification and conformity assessment route shape what evidence is expected and how it will be assessed. MDR clinical evaluation and IVDR performance evaluation are built differently.

Questions we work on

  • How many patients or samples do we need?
  • Can we use retrospective data?
  • Do we need an external validation study?
  • Are we validating the right thing?
  • Are we doing more than the regulation actually requires?
  • Can one study support more than one market?
  • Will an EU claim create problems for a later FDA pathway?

Services for evidence and validation

Clinical and performance evidence

What evidence do we actually need to support our medical device or IVD?

AI validation and evidence

How do we demonstrate that our AI-enabled medical device works reliably and safely for its intended medical use?

Notified Body readiness

Are we ready to submit to a Notified Body?

View all services

Primary regulatory sources

Last reviewed: October 2026

Have an evidence question?

Tell us what the product is for, what evidence you already have and the decision you need to make.

We start from what you already have, and say plainly if the existing evidence is enough.

Discuss your evidence question

The first conversation is free and carries no commitment.