Inferify
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Built for EU MDR clinical evidence workflows

Clinical evidence,
continuously traceable.

Turn your existing CER and supporting documentation into a traceable evidence review and updated draft.

Built for medical device regulatory and clinical teams.

See how it works ↓
The problem

Clinical evidence changes.
Your CER has to keep up.

When new clinical studies, PMCF data, or post-market evidence arrives, regulatory teams have to determine which existing claims it affects, whether those claims are still supported, and what needs to change.

Today, much of that review is manual.

  1. 1New evidence
  2. 2Which claims does this affect?
  3. 3What needs to change?
  4. 4Where is the proof?
What changed

See every claim, its status, and its source.

Select a claim to see the exact passage behind the finding.

CardioTrack ECG Monitor · Evidence reviewSynthetic example
WHAT CHANGED
SUPPORTING EVIDENCE
Clinical performance remained stable through 12 months
CER §6.3 · p.21
PMCF_Report_2026.docxp. 14
SUPPORTS · NEW SINCE LAST CER

“Across 12 to 24 months of follow-up (n = 1,148), AF detection sensitivity remained between 95.1% and 96.8%, with no statistically significant decline over time.”

✓ Verbatim from the uploaded source
How it works

From your current CER to a reviewable update.

01

Upload

Add your current CER and supporting clinical evidence.

02

Review

Inferify identifies which claims remain supported, what changed, and what requires review.

03

Update

Generate proposed CER revisions with every factual change linked back to its source.

Our method

No evidence,
no claim.

  • Inferify does not generate unsupported regulatory language.
  • Every evidence-based finding traces back to an uploaded source.
  • Every proposed factual update must remain connected to verified evidence.
  • Supporting evidence can be opened and reviewed directly.
  1. Claim
    Clinical performance remained stable through 12 months.
  2. Source
    PMCF Report · Page 14
  3. Exact excerpt
    “Across 12 to 24 months of follow-up (n = 1,148), AF detection sensitivity remained between 95.1% and 96.8%…”
  4. Proposed revision
    PMCF data now extend follow-up to 24 months (n = 1,148), with sensitivity remaining between 95.1% and 96.8%. [1]
Why Inferify

Built for work that has to hold up to review.

TRACEABLE

Every finding links back to the exact supporting source.

REVIEWABLE

Inferify surfaces conflicting and missing evidence instead of hiding it.

CONTROLLED

Nothing replaces professional judgment. Proposed updates remain reviewable, editable, and rejectable.

PERSISTENT

Evidence relationships remain attached as the CER evolves.

Built for
  • Regulatory Affairs
  • Clinical Affairs
  • Quality
  • Medical device founders
  • Regulatory consultants

Especially teams maintaining EU MDR clinical evidence across one or more devices.

Keep your clinical evidence connected to every claim it supports.

Inferify is opening access to medical device teams and regulatory professionals.