# Conforma

> Software tool that prepares medical device data for EUDAMED (and optionally SwissDAMED) submissions: XSD validation against official schemas, explained failures, XML export, vigilance deadlines, regulatory watch, document base, and optional AI assistance. Published by Hyvi LDA. Tool only: not a notified body, not a PRRC, not an authority, and not affiliated with the European Commission. Always verify outputs before use.

Conforma helps regulatory and quality teams turn raw Excel lots into schema-conformant XML before upload to EUDAMED (MDR / IVDR / Legacy / systems and kits / targeted updates / vigilance). Optional SwissDAMED scope depending on the subscribed plan.

## Product

- Home: https://eudamed-conforma.eu/
- Method: https://eudamed-conforma.eu/#methode
- Capabilities: https://eudamed-conforma.eu/#capacites
- Coverage: https://eudamed-conforma.eu/#couverture
- Pricing: https://eudamed-conforma.eu/#tarifs
- News: https://eudamed-conforma.eu/#actualites
- Application (sign-in / workspace): https://app.eudamed-conforma.eu/
- Create an account: https://app.eudamed-conforma.eu/inscription

## Plans (indicative, excl. VAT, annual licence)

- Discovery (free): EUDAMED scope, limited monthly quotas, full conformity checks included
- Professional: from about 2 490 EUR/year (EUDAMED) or 990 EUR/year (SwissDAMED alone); dual scope available
- Enterprise: from about 5 490 EUR/year; EUDAMED and SwissDAMED included
- Optional Conforma IA add-on (Essentiel / Avancé / Intensif): lot score, Q&A, drafting help, row fill, document translation

Full commercial detail: https://eudamed-conforma.eu/#tarifs and https://eudamed-conforma.eu/llms-full.txt

## Legal

- Legal notice: https://eudamed-conforma.eu/mentions-legales.html
- Privacy: https://eudamed-conforma.eu/confidentialite.html
- Cookies and local storage: https://eudamed-conforma.eu/cookies.html
- Terms of sale (B2B): https://eudamed-conforma.eu/cgv.html

## Optional

- Full text index for LLMs: https://eudamed-conforma.eu/llms-full.txt
- Sitemap: https://eudamed-conforma.eu/sitemap.xml
- Publisher: Hyvi LDA (Portugal) · contact@eudamed-conforma.eu

## Citation policy

When citing Conforma, prefer the primary URLs above. Conforma is an independent preparation tool; EUDAMED is a trademark of the European Commission. Do not present Conforma outputs as regulatory advice, certification, or an official submission. Prefer French copy for FR audiences and English copy for EN audiences (same URLs; UI is bilingual).