AI-native regulatory intelligence for European medical device RA work. Citation-grounded. Human-in-the-loop on every output.
The same pipeline every consultant runs on every client device — from intended use through a signed, citation-grounded report that keeps watching the corpus on your behalf.
01
A guided intended-use workflow captures the device, its users, and its claims. Risk flags surface ambiguous or scope-creep language before it reaches a classification call. The output is a defensible intended use statement, reviewable line by line.
02
Evalda runs the device through EU MDR, EU IVDR, US FDA, and the AI Act in parallel, with citations to the specific guidance documents used in each verdict. Applicable ISO and IEC standards arrive mapped per device class. PubMed retrieval drafts a MEDDEV 2.7/1 Rev 4 literature section ready for partner-level edit.
03
A qualified human reviews and signs every output. Every classification stores its source citations; when one of those guidance documents updates, the consultant gets an alert listing the client devices that may need rechecking. Coverage compounds.
Capacity is the bottleneck. The repetitive parts compound — classification under MDR Annex VIII Rules 1–22, IVDR Annex VIII Rules 1–7, and FDA 21 CFR 820. Standards selection per device class. PubMed scans drafted to MEDDEV 2.7/1 Rev 4. Tracking MDCG amendments, FDA guidance changes, AI Act milestones, and the EUDAMED 28 November 2026 operational mandate.
Evalda automates the repetition. A senior reviewer signs every output.
13–18 months
Notified Body queue for MDR conformity assessment
Source · TEAM-NB · MedTech Europe
~85%
of IVDs now require NB review under IVDR (up from ~7% under IVDD)
Source · European Commission
60+
MDCG documents to track since MDR took effect
Source · EC · MDCG
Each output stores the source documents it cited. Reviewable line by line before sign-off.
Multi-regime classification across EU MDR, EU IVDR, US FDA, and the AI Act in a single report — with confidence indicators and citations to the specific guidance documents used.
A guided workflow that produces a defensible intended use statement. Risk flags for ambiguous or scope-creep language. Recommendations to tighten or broaden scope.
For each classified device: applicable ISO and IEC standards with the role of each standard, contextual notes specific to its class, and tooling suggestions for implementation.
Automated PubMed retrieval driven by the device's intended use, with abstract-level relevance scoring and a literature review section drafted in MEDDEV 2.7/1 Rev 4 format. EMBASE, Cochrane, and full-text are v2.
A curated stream of MDR/IVDR amendments, MDCG documents, FDA guidance changes, EUDAMED milestones, and AI Act events — filtered for European medical device work. About 5–10 high-quality items per week.
Every classification stores its source citations. When one of those documents updates, the consultant gets an alert listing the client devices that may need rechecking. Coverage compounds with every classification.
What a partner-led RA consultancy notices in the first month of running Evalda across its client roster.
Days → working session
First-draft classification compresses to hours. Senior time goes to review, not drafting.
Cited per device class
ISO and IEC selections arrive with the role of each standard already documented. Junior consultants stop guessing.
MEDDEV 2.7/1 Rev 4
PubMed scans land as a structured literature review section, ready for partner-level edit before client delivery.
5–10 per week
MDR / IVDR / MDCG / FDA / EUDAMED / AI Act, filtered for European medical device work. Not a Google Alerts flood.
Coverage compounds
Each classification adds to the corpus your firm watches. At 50 client devices, the dashboard is yours.
Partner-ready artifacts
Every output is citation-grounded throughout. A senior reviewer edits, signs, and delivers — without rewriting the reasoning.
Every classification runs each regime in parallel and consolidates the findings into a single citation-grounded report.
MDR
EU Medical Device Regulation
Reg. 2017/745
Annex VIII Rules 1–22 · Annex IX–XI conformity assessment
IVDR
EU In Vitro Diagnostic Regulation
Reg. 2017/746
Annex VIII Rules 1–7 · Class A / B / C / D
FDA
US Food and Drug Administration
Reg. 21 CFR 820
510(k) predicates · De Novo · SaMD guidance
AI Act
EU AI Act
Reg. 2024/1689
High-risk AI requirements · interaction with MDR / IVDR
Every output traces back to the specific source document used in the reasoning. A qualified human reviews and signs off on every deliverable. Evalda is not agentic, not autonomous, and not a substitute for senior judgement.
Corpus sources
v1 ships
v2 roadmap
Evalda is working with a small number of European RA consultancies as design partners during the v1 build. Weekly working sessions, early access to v1 modules as they ship, and a 30% discount on Year 1 SaaS.
No equity. No joint venture. No exclusivity. Applications open through Q3 2026.
Built in conversation with RA professionals in Sofia, Stockholm, Munich, and Amsterdam.
We'll spend half an hour on a video call. Bring a device you've worked on — IVD, SaMD, or traditional MedTech, in progress or already on market — and we'll walk through it together in Evalda: classification, standards, literature, change alerts. You see where it fits in your workflow. Questions welcome at any point.
Prefer email? Use the form. We reply within one working day.