5 specialized tools · 90 unit tests · live FastAPI backend

IVDR compliance,compressed from months to hours.

Conformly is an autonomous AI co-pilot for in-vitro diagnostic manufacturers entering the EU under Regulation (EU) 2017/746. It tracks every client across a 45-step program, parses Notified Body letters in 30 seconds, and benches the technical file against IVDR Annex I clause-by-clause — all driven by Gemini 3.

Try the live demo See the portfolio dashboard

no demo trick · the dashboard reads live markdown from this repo's vault/

Why this matters

IVDR is a multi-million-euro,
multi-year program. Conformly cuts it in half.

-78%

Time

beforeManually triaging a Notified Body deficiency letter and mapping each finding to IVDR clauses takes a senior regulatory affairs lead 4–6 hours.

afterConformly returns a structured deficiency plan, severity, evidence required, and a draft response skeleton in under 30 seconds.

-65%

Cognitive load

beforeA GSPR gap analysis touches 20+ IVDR Annex I clauses across thousands of pages of regulation, MDCG guidance, and ISO standards.

afterOne Gemini 3 Pro call reads the entire curated checklist + the client's whole dossier in a single 2M-token context — every clause scored, every gap quoted.

-40%

Consulting fees

beforeA typical IVDR Class C submission costs €350k–€800k in consulting alone, with consultants billing manual triage and document drafting at €1.5–2.5k/day.

afterConformly drafts the repeatable 70% (status reports, NB responses, gap analyses), leaving consultants free to focus on the irreplaceable 30%.

The complexity

IVDR is the most complex MD regulation ever passed in the EU.

The 2017/746 regulation reclassified 80%+ of IVD devices into higher compliance tiers. What used to be a self-declaration is now a full Notified-Body assessment plus EMA opinion plus EU reference lab review.

22
GSPR clauses every device must satisfy
45
steps in a typical engagement, signature to certificate
60+
sub-steps in a Clinical Performance Study (CPS) alone
24
EU official languages every IFU must support (Article 17)
2,500+
pages of regulation + MDCG guidance + ISO + CLSI to internalise
30+ mo
average Class D submission timeline today, end-to-end

The product

Five focused tools. One regulatory-affairs co-pilot.

The agent calls these tools the way a senior consultant would dictate to a junior — one specific task at a time, always citing the source document, never going off-script.

Triage a Notified Body letter

30 s vs. 5 h

A BSI / TÜV SÜD / DEKRA letter goes in — English, German, or Italian. A structured deficiency plan comes out: IVDR clause map, severity, evidence required, draft response skeleton.

conformly_parse_nb_letter()

Bench against IVDR Annex I

2 min vs. 3 days

One call, 22 GSPR clauses, one structured report. addressed / partial / open / n-a, with quoted evidence per addressed clause and a concrete recommended action per gap.

conformly_gspr_gap_analyzer()

See the whole portfolio

instant

Class, phase, day-in-journey, risk level, next deadline — every active engagement on one screen. Sort by risk to know who needs you today.

conformly_list_clients()

Open one file

instant

A single client dossier becomes a typed status object: GREEN LIGHTs passed, open risks with severity, soonest deadline, communication log.

conformly_get_client_status()

Cite the regulation

cached forever

A live catalog of every IVDR / MDCG / ISO / CLSI document in the vault. Filter by family, query by substring, let the long-context LLM do the reading and the quoting.

conformly_search_regulation()

How it works

Plain markdown. Long-context LLM. Git for memory.

No vector database. No embeddings. No RAG infrastructure. The agent reads files the way a consultant would — by path, by section, by quote.

Vault = source of truth

Clients, projects, regulations, NB letters — all markdown with YAML frontmatter. Git-versioned, diff-able, auditor-friendly. ISO 13485 reviewers love it.

Hermes Agent runtime

The agent loop, model routing, and skill dispatch come from the NousResearch Hermes Agent project. We plug in five custom Python tools through its standard plugin interface.

Gemini 3 Pro + Flash

Gemini 3 Pro handles deep reasoning (GSPR analysis, NB letter parse) with its 2M-token context window. Flash handles fast triage and selection.

Production-ready deploy

One Vultr VPS, one shell script, two services (FastAPI + Next.js) behind nginx, Let's Encrypt for HTTPS. Costs €15/month to run.

  ┌─────────────────────────────────────────────────────────────────────┐
  │                       Conformly architecture                        │
  ├─────────────────────────────────────────────────────────────────────┤
  │                                                                     │
  │   user / consultant                                                 │
  │         │                                                           │
  │         ▼                                                           │
  │   ┌───────────────────┐   tool_call   ┌──────────────────────────┐  │
  │   │  Hermes Agent     │ ────────────► │  Conformly plugin (5)    │  │
  │   │  + Gemini 3 Pro   │ ◄──── JSON ── │  • get_client_status     │  │
  │   │  + Gemini 3 Flash │               │  • list_clients          │  │
  │   └────────┬──────────┘               │  • search_regulation     │  │
  │            │                          │  • parse_nb_letter   ⚡  │  │
  │            │                          │  • gspr_gap_analyzer ⚡  │  │
  │            │                          └────────────┬─────────────┘  │
  │            │                                       │                │
  │            │                                       ▼                │
  │            │                          ┌──────────────────────────┐  │
  │            │                          │   vault/  (markdown)     │  │
  │            └────────────HTTP─────────►│   clients/, projects/,   │  │
  │                                       │   raw/regulations/,      │  │
  │                                       │   notes/  ←──git─────┐   │  │
  │                                       └──────────────────────┼───┘  │
  │                                                              │      │
  │                              ⚡ = LLM-backed tool            │      │
  │                              ◀ everything is auditable in git┘      │
  └─────────────────────────────────────────────────────────────────────┘

Read-only by default

Reads and drafts run free; any outbound action (CAPA, submission, email) pauses for a human approval routed to Slack.

Cite or refuse

Every regulatory answer carries a document ID + section number. If the source is silent, the agent says so rather than invent.

Audit trail by construction

Every tool invocation writes one JSON line to ~/.conformly/audit.log. ISO 13485 evidence ready out of the box.

No vendor lock-in

Markdown vault, standard OpenAI tool-call schemas, open-source Hermes runtime. Swap LLM providers in one config line.

In practice

Three scenarios. One regulatory week, replayed in 90 seconds.

Act I

A Notified Body deficiency letter lands at 9:00 AM.

manufacturer

before — manual

A 4-page BSI letter with 4 findings: precision, clinical, software, stability. Your RA lead spends the morning reading, classifying, mapping each to IVDR clauses, drafting a response outline, escalating to the project sponsor.

after — Conformly

Conformly parses the PDF, extracts the four deficiencies with IVDR Annex I references, flags clock-stop status (yes, 60-day window), and drafts the point-by-point response. Total wall-time: 30 seconds.

manual: 4–6 hConformly: 30 s

Act II

The sponsor asks: 'are we ready for submission?'

regulatory affairs lead

before — manual

The traditional answer is a 3-day cross-functional sprint: pull the technical file, cross-reference 22 GSPR clauses, interview each team owner, write a gap report. Then re-do it next week because something changed.

after — Conformly

One conformly_gspr_gap_analyzer call. Twenty-two clauses scored, evidence quoted, gaps named, recommended actions ranked by priority. Reproducible from any commit — git checkout the past, see the past gap report.

manual: 2–3 daysConformly: 2 min

Act III

Monday morning portfolio review.

CRO operations director

before — manual

A spreadsheet (always slightly out of date), three open chat threads, and a vague feeling about which client is closest to a deadline. PM has to ping each project lead individually before the 10:00 standup.

after — Conformly

One screen. Every active engagement, sorted by risk. Day-in-journey. Days since last contact. The soonest next deadline, by date. Click any card to drill into the source file.

manual: 45 minConformly: instant

Play these scenarios live

running right now

Active clients in the vault: 3
High-risk engagements: 2
IVDR classes covered: 3

Sit down with the agent for 90 seconds.

Three scripted scenarios, real tool outputs, every assistant message exactly what a sponsor would see on Slack today. Replay any run from your history.

Start the demo