Classification, intended use, literature, and change alerts across your client portfolio. Every output traced to its source, signed off by a named consultant.
Capacity is the bottleneck. The repetitive work compounds – device classification across the EU and US, standards selection for every device class, literature reviews, and keeping pace with a constant drift of new guidance. With EUDAMED legacy device registration closing on 28 November 2026, the load only grows. None of it is hard for a senior consultant – all of it eats the hours they should be billing.
Evalda automates the repetition. A senior reviewer signs every output.
60+
MDCG documents to track since MDR took effect
Source · EC · MDCG
28 Nov 2026
EUDAMED legacy device registration closes
Source · European Commission
Clients, devices, analyses, statements, reviews, and alerts — structured the way your files already are. Work the portfolio across every client, or open a single device and see everything it carries.
Owner, consultant, and reviewer roles, with the reviewer read-only except for regulatory sign-off. Invite your team by email. Tenant isolation is enforced at the data-access layer. Every export carries your logo, not ours.
Structure
Every analysis, statement, review, and sign-off is attributed to a named person on an append-only audit trail.
Nordhavn Regulatory
Consultancy
OncoGuide NGS
OncoGuide Diagnostics · Class C · IVDR
OncoGuide NGS
Regulatory Intelligence Report
ID: cms8kcomp000…
In Vitro Diagnostic Medical Device
Classification assessment
Current class
Class C
High confidence
IVDR Annex VIII Rule 3 explicitly classifies companion diagnostics as Class C, and the product's intended purpose — interpreting NGS tumour biopsy data to guide targeted cancer therapy selection — meets the definition of a companion diagnostic under IVDR Annex VIII Rule 3.
The software analyses laboratory-derived genomic data (NGS from a tumour biopsy) to identify actionable variants and guide selection of a targeted therapy, which constitutes an in vitro diagnostic device under IVDR Article 2(2). As a companion diagnostic, IVDR Annex VIII Rule 3 mandates Class C classification regardless of format or delivery mechanism.
Regulatory basis: IVDR (EU) 2017/746, Annex VIII Rule 3 (companion diagnostic — Class C); MDCG 2021-24 (software as IVD); MDCG 2019-11 (AI/ML SaMD classification)
Bring a device you've worked on and we'll run it live.
General-purpose models have no curated regulatory corpus, store no citation history per device, produce no signed artefacts, and never tell you when the underlying guidance changes.
Grounded, or refused.
If Evalda has no source corpus for the regime you selected, it flags the analysis and blocks the export. It will not ship a deliverable its citations cannot support.
Every claim traces to a passage.
Not a document name — the retrieved text, in a source drawer, next to the conclusion that rests on it.
Versioned corpus.
Every report records which snapshot of the regulatory corpus it reasoned over, with the retrieval date.
A named human signs everything.
Evalda produces drafts and structured analyses. It never produces a final regulatory deliverable.
Append-only audit trail.
Who ran what, on which device, when. Workspace-level and per-device.
Your data never trains a model.
Client work stays inside your workspace.
Export disabled – UK MHRA is not corpus-grounded yet.
UK MHRA analysis is not grounded in the Evalda source corpus
The Evalda source corpus does not yet cover UK MHRA guidance, so citations cannot be confirmed to support the concluding regime. Document export is disabled for this report — conclusions cannot be traced to verifiable source passages. MHRA corpus grounding is on the roadmap.
The product refusing to export is the feature. A report Evalda cannot ground is a report you should not put your name on.
Corpus sources
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
Risk-based device classification and conformity assessment routing.
IVDR
EU In Vitro Diagnostic Regulation
Reg. 2017/746
Class A–D classification under the rules-based system.
FDA
US Food and Drug Administration
FD&C Act §513
510(k), De Novo, and PMA pathway analysis.
What a partner-led RA consultancy notices in the first month of running Evalda across its client roster.
Review, not drafting
First-draft classification arrives cited throughout, so senior time goes to review and judgement rather than drafting.
Reviewable line by line
Every verdict carries the passage it rests on. A partner edits and signs without reconstructing the reasoning first.
Juniors stop guessing
ISO and IEC selections arrive with the role of each standard already documented against the device's class.
Compounds with every device
Each classification enlarges the corpus your firm is monitored against. At 50 client devices, the alert dashboard is yours alone.
Regulatory work runs on knowing exactly where a tool's scope ends. The first list is in the product now. The second is named rather than implied, so you can plan around it.
Evalda is not a QMS, not a submission system, and not a notified body workflow tool.
Live today
On the roadmap
Evalda is working with a small number of European RA consultancies as design partners. Weekly working sessions and the full platform from day one: €1,500 for the first 30 days, then €4,500 for the following 60. Both fully credited against year one.
The QMS Integration Pack is included: IQ/OQ protocols and supplier qualification evidence, so Evalda clears your own ISO 13485 supplier controls before any client work enters the platform.
Five design-partner slots. Applications close 31 December 2026.
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, intended use, 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.