Skip to content

AI-assisted CER authoring — inside Microsoft Word

Generate structured first drafts of Clinical Evaluation Reports for medical devices from clinical data, literature, and post-market surveillance — aligned to EU MDR expectations, with full traceability.

Request a demoSee how Asthra works

Asthra AI automates Clinical Evaluation Report (CER) authoring by converting clinical investigation data, literature, post-market surveillance, and prior CERs into structured section drafts aligned to EU MDR Annex XIV and MEDDEV 2.7/1 Rev 4. Writers stay in control of provenance, and every claim is traceable to source — all inside Microsoft Word.

Who this is for

Medical device manufacturers

Class IIa, IIb, and III device teams preparing or maintaining CERs under EU MDR.

CRO and regulatory consultancies

Service providers writing CERs for device sponsors on tight notified-body timelines.

The challenge of CER authoring

Four bottlenecks that dominate CER cycle time

Literature is scattered and re-evaluated every cycle

Every CER update re-runs literature searches, re-screens papers, and re-assesses relevance. Most of this is mechanical — hunting the same journals for updates since the last evaluation.

Rewrites dominate updates

Prior CER sections are often re-typed rather than reused. Unchanged evidence still gets re-stitched into the new document, because writers have no safe way to reuse with confidence.

Post-market data is painful to weave in

Complaint logs, vigilance data, and field safety notices sit in separate systems. Incorporating them consistently across clinical sections is tedious and error-prone.

Traceability across the body of evidence is fragile

Notified bodies expect a clear line from each conclusion back to the evidence. Maintaining that line manually across dozens of sources is the single biggest source of review comments.

How Asthra supports CER authoring

From a curated evidence library to a structured CER first draft

1

Pre-configured CER structure

On onboarding, the Asthra team configures a CER template aligned to your notified body's expectations. Section prompts and provenance rules are set per section — clinical background, clinical data, literature, PMS, benefit-risk.

2

Upload clinical evidence and prior CER

Writers upload the device's technical file, clinical investigation reports, complaint and vigilance data, risk management documentation, literature search outputs, and the previous CER where applicable.

3

Approve the agent's plan, then generate

Asthra proposes which sources to use per section. Writers approve or adjust before drafting starts. The agent then drafts, cites, and flags gaps.

4

Update-mode for existing CERs

For CER updates, Asthra marks each section as reuse, revise, or rewrite based on what changed. Writers override per section. Unchanged evidence is preserved with full provenance intact.

5

Chat-mode refinement and sign-off

After the draft lands in Word, writers can ask the agent why specific literature was cited, re-run a search with tighter inclusion criteria, or swap a source. Clinical evaluators retain full sign-off authority.

Evidence and traceability built in

Notified-body-grade audit trail from the start

Closed-system retrieval

Asthra uses only the evidence you provide, including writer-approved literature searches. No open-internet retrieval. No training-knowledge leakage.

Missing evidence is flagged

If a required piece of clinical or PMS data is missing, Asthra surfaces it explicitly — in the draft and in the ledger — so the evaluator knows before sign-off.

Two-level traceability

Document-level provenance for every section plus sentence-level citations with file, page, and exact snippet. An immutable transaction ledger is embedded in the .docx.

Writer-controlled reuse

For CER updates, every reused passage keeps its original provenance. Writers can change reuse mode per section at any time and regenerate.

What Asthra helps with

Asthra excels at

  • •Consolidating multi-source clinical evidence into narrative
  • •Weaving PMS and vigilance data into clinical sections
  • •Literature summarisation with full citation
  • •CER updates: detecting what changed and preserving what didn't
  • •Maintaining consistent structure across device families

Out of scope

  • •Clinical judgement or benefit-risk sign-off
  • •Primary statistical reanalysis of clinical data
  • •Open-internet literature browsing outside approved sources
  • •Regulatory submission decisions

CER-specific questions

Typical CER inputs include the device's technical file, clinical investigation reports, literature search results, post-market surveillance data, complaint and vigilance data, risk management documentation, and the previous CER where applicable. Asthra accepts these in PDF and Word and works with large, figure-heavy sources.
Yes. CER structures and writing instructions are built to align with EU MDR (Regulation 2017/745) Annex XIV and with MEDDEV 2.7/1 Rev 4 expectations. Writers validate the specific interpretation for each device during onboarding, so the generated structure matches your notified body's expectations.
Yes. For a CER update, Asthra can reuse prior content where evidence has not changed (reuse), refresh sections where only new data needs to be woven in (revise), and rebuild sections where the clinical picture has shifted materially (rewrite). Writers control which mode applies per section.
Literature searches are run against writer-approved sources (typically PubMed and similar). Each search is plan-reviewed, and every cited paper lands in the provenance ledger with author, year, and passage. Asthra does not browse the open internet — literature inputs are explicit and auditable.
Asthra drafts the report. It does not replace the clinical evaluator. Clinical judgement, benefit-risk conclusions, and sign-off remain with qualified medical and regulatory professionals. Asthra also does not perform statistical recalculation on clinical data — it reports what your sources contain.
For a typical device CER with a well-curated source library, a structured first draft lands in well under a day of agent time — the long tail is writer review and clinical interpretation, which is exactly where writers should be spending time.

See Asthra draft a CER

Request a personalised demo. We'll run Asthra against a device you care about and walk through the provenance trail end to end.

Request a demoExplore other use cases

Last updated: 16 April 2026