EryonOne's changes, dated. What is shipped carries its production date, what is not carries a quarter. This page lists the structural workstreams: individual fixes and adjustments are not included.
United States medicine and device regulation, currently being integrated. Intended scope: prescription drug advertising, device labelling, electronic records.
Apply the suggested correction on a finding, adjust it, then approve it, without leaving the project or reopening the document elsewhere.
Once findings are arbitrated and corrections approved, a final report carrying the decisions taken, to attach to the file.
The report already downloads as PDF, CSV and HTML. It will receive a timestamped fingerprint and a table of contents, for internal audit and regulatory submission requirements.
Hand back the corrected document, not only the list of corrections to carry over by hand. This is where the product is heading: the review ends in the file, not in a report.
Document control, review and approval of documents, for medical device manufacturers. Prioritised alongside the FDA.
Today a review runs on a digital PDF. Word and PowerPoint will follow, with the same traceability back to the quoted passage.
Suggest an improvement from the roadmap, put it to the vote of other users and be notified when it reaches production. Pushed back behind the review workstreams.
Each framework's source page is re-checked periodically. When the text changes, the regulatory team is alerted and the coverage is revised.
Encrypted backups verified before every deployment, a fourteen-day retention, and an admin screen listing the backups present on the host.
A client account can invite several users. Four roles (owner, admin, member, viewer), a shared credit ledger, an audit of actions per user, and switching between organisations.
Incidents confirmed by the team are published on an open page, with the history of the last ninety days.
The report comes out in French or English, whatever the language of the reviewed document, which may be Spanish, German, Italian, Portuguese or Dutch.
Card payment, a monthly subscription renewed until you ask us to stop it, credit packs at a firm price and free top-ups from 100 credits.
Every organisation has a referral link and sees the sign-ups it brought in. The reward is agreed with the team.
By email or authenticator app (TOTP), with revocable trusted devices and a block after five wrong codes. Hardened in early September: emailed codes now expire after an hour.
Every review produces a report downloadable in all three formats, findings, quoted passages and sources included.
The "Resend email" button can no longer be used in a loop. The delay increases progressively (60s → 5min → 30min → 2h → 24h), with automatic reset after 24h of inactivity. Atomic database protection against double clicks. The verification waiting page shows the countdown in real time.
Reviews are processed by Claude (Anthropic) in real conditions: versioned instructions, per-stage traceability, usage tracking, circuit breaker on provider incidents.
No item in this category.
Suggestions put to a vote are still at the planned stage. Until then, write to us, or create your account to follow the updates.
Upload your document, pay online, instantly receive a compliance report. Price known upfront, zero commitment.
What AI-assisted review changes for a regulatory affairs team: spot, justify, arbitrate. The decision stays with your team.
MDR by class, IVDR, ANSM doctrine, Directive 2001/83/EC, French Public Health Code: the exact scope of every active framework, and the ones planned next.
Procedures, charters, claim matrices, licensed standards: the sector-by-sector list of documents to upload as requirements in EryonOne.
Spot the sensitive passages in a health promotional material (claims, benefit/risk balance, consistency with the SmPC) before internal approval.
EryonOne helps compare a patient leaflet and an SmPC, both ways, when the documents are provided as main document and reference.
EryonOne reviews protocols, synopses and investigator brochures: internal consistency, traceability to your references, format and language.