Login Book a demo

How it works

The design record that becomes your submission.

Requirements, risks and test evidence live in one linked record. Allele plans your FDA pathway, shortlists your predicate and assembles the 510(k) package from that record, and no AI draft counts until a person verifies it.

Guided, not outsourced.

  • ISO 13485
  • Part 11-ready records
  • ISO 14971
  • IEC 62304
  • IEC 62366
  • FDA QMSR

An eQMS keeps your paperwork. It doesn't get you to market.

Startups and consultants end up stitching a document system to a pile of FDA guidance PDFs and a consultant's inbox. The strategy (the part that actually decides whether you get cleared) lives nowhere.

Which pathway?

510(k), De Novo, PMA, or exempt? The wrong call costs months and hundreds of thousands. Most tools stay silent on it.

Which predicate?

Substantial equivalence makes or breaks a 510(k). A document store won't find your predicate or flag its recalls.

Now assemble it

Turning your records into an FDA-format submission is the real work, and it's where an eQMS hands you back a blank template.

Your device's FDA class reshapes the whole workflow.

Pick a class and watch the path change: the same engine that runs inside the product. No generic checklist; the route that actually applies to your device.

  1. Step 1

    Device profile

    Set the class: it drives everything

  2. Step 2

    Predicate search

    Screened on intended use, recall-flagged

  3. Step 3

    Confirm pathway + Pre-Sub

    510(k) chosen on the predicate; questions to FDA

  4. Step 4

    Records

    Requirements · Risk · Usability · tests

  5. Step 5

    Compile the 510(k) package

    Pulled from your records

  6. Step 6

    You file · we track

    CDRH Portal · ~90-day clock

Class II → 510(k): predicate-driven. Show substantial equivalence, prep a Pre-Sub, then assemble the package. You file; FDA goal ~90 days.

510(k) user fee $28,653, or $7,163 for a small businessFDA review goal: 90 FDA days. FY2027 FDA figures, a planning estimate: confirm current fees with FDA.

Find your predicate

A vetted predicate shortlist in minutes.

Your device Predicate Its predicate Further back

Every candidate is screened against your intended use, ordered so complete devices outrank accessories and then by technology match, flagged for recalls and adverse events, and linked to the exact page and quote in FDA’s clearance summary. You can see and correct how your intended use was read, and name predicates you already know so they’re always assessed.

  • “Why this match” reasoning, factor by factor
  • Recall / MAUDE safety flags surfaced
  • Watch a predicate, product code or applicant: new recalls, adverse-event signals and clearances, checked daily and flagged in the app
  • Predicate lineage (what your predicate cited, and who cites it), De Novo decisions in the search, and filters when the list calls for them
Show 4 more
  • MAUDE trends and reports, a life-cycle view per product code and a recall browser, from FDA’s public data
  • Ask a cleared device’s 510(k) document a question and get its own words with page numbers
  • A substantial-equivalence comparison with your predicate, each fact cited to its 510(k) summary (PDF + CSV)
  • A citation cross-check across your package (records, FDA decisions, eCFR sections, guidance titles, standard editions), and every fact in the SE comparison labelled confirmed, claimed, inferred or unknown
The predicate search screen: ranked candidates for a pulse oximeter, each with its K-number, clearance date, intended-use check and source link.
Predicate search: every candidate screened, ranked and linked to FDA's record. Sample data.

Know your path

See your FDA route before you spend on it.

A class-aware pathway assessment, with a Pre-Submission (Pre-Sub) you can prepare and send yourself.

  • Pathways scored from FDA’s records for your product code, every point sourced; how defensible your predicate is; a device-change (letter to file) questionnaire following FDA’s guidance; and a one-file strategy report
  • Pre-Sub prep with a question-quality check, questions ranked by how much the answer would change your plan
  • AI wording advice on your intended use against the predicate’s indications, and a simulated reviewer’s likely questions tied to your records: opinions you verify, never approval odds
  • FDA device guidance tracked daily, new and revised documents flagged where your records cite them, and a weekly FDA digest
Show 3 more
  • PubMed literature saved to each device with its PMID, research memos where every claim cites FDA’s records or a saved abstract, and side-by-side strategy scenarios
  • A classification rationale PDF to share with investors or clients
  • A cost & timeline estimate using current FDA user fees
The confirm-pathway screen: 510(k) recommended for a Class II device, with the points behind it, the chosen predicate's defensibility and what the route takes.
Confirm pathway: the route, why it fits, and what it takes. Sample data.

Prove every answer

AI provenance you can defend.

Every AI-touched passage is tagged and stays "suggested" until a human verifies it. Only verified content counts toward readiness, so you always know what the machine wrote and what you approved.

  • Per-line source: you, AI, or verified
  • Nothing is "done" until a person signs off
  • An audit trail that shows your reasoning
  • Exports show each signer’s role at the time they signed
Show 3 more
  • Every AI edit shown as a diff before it changes anything; redrafts proposed when a record it traces to changes; a quality score for each submission section, with its reasons
  • Ask: answers cited to your own records, or no answer
  • Ask a platform expert to sign off a record: they get time-limited, read-only-plus-sign-off access, and their sign-off lives in the record
Verified · you

Intended use matches the cleared predicate's indication.

AI draft · unverified

Proposed substantial-equivalence rationale. Review before it counts.

Edited · you

Low-perfusion limitation flagged for the IFU.

The submission readiness screen: a 510(k) laid out by eSTAR section, with progress rings and an uploaded test report the AI suggests a section for.
Submission readiness: what your records fill, what the AI drafts for you to confirm. Sample data.

One connected workspace

One connected design record, from user need to DHF.

Every requirement, output, test, risk and usability task lives in one linked record, with every version kept. Traceability isn't a spreadsheet you rebuild before an audit. It's how the work is stored, so it holds up through every change. Already have a requirements spec? Upload the PDF or Word file and the AI pulls out the requirements it states, each with the exact quote and page, for you to tick and verify.

  1. User needswhat the device must do, for whom
  2. Design inputssystem & software requirements
  3. Design outputsarchitecture, components, SOUP
  4. Verificationtest protocols & logged runs
  5. Validationusability tests; the pivotal study for PMA

Risk management (ISO 14971): hazards, risks and controls link to the inputs they constrain and the tests that prove them.

The same record feeds the DHF, submission readiness and the QMSR gap check. Fix something once and every view reflects it.

The design records trace map: user needs, design inputs, outputs, verification and validation in columns, with records flagged for re-review.
The trace map: every link from user need to validation, with what needs re-review. Sample data.

You change a requirement

REQ-012 · v3 → v4

A new version is saved and everything downstream that was complete is flagged, so nothing silently goes stale.

  • TEST-021 · SpO₂ accuracy protocolNeeds re-review
  • RISK-004 · over-reads at low perfusionNeeds re-review

You log a passing test run

TEST-021 · run 3

One action closes the chain: the test, the requirement it verifies and the risk it controls all update together.

  • REQ-012 · SpO₂ accuracyVerified
  • RISK-004 · over-reads at low perfusionAcceptable, verified

Illustrative example. Record IDs are your own.

Guided risk management

An FMEA-style flow builds the hazard → risk → control chain in one step and derives its status. Your risk plan is kept and locked per device.

Design reviews with phase gates

7 phases for a 510(k), 12 for a PMA. Approval goes through sign-off with a date and attendees, and closing an action item requires evidence.

A DHF compiled from the record

8 elements for a 510(k), 14 for a PMA. Evidence tables are built from your real links, not retyped, then signed off and exported as a PDF binder.

Coverage and sanity checks

See what's verified, what has no completed test, which risks are still unacceptable and what was flagged after a change, ordered by severity.

AI that respects the record

Draft requirements, flag ones that can't be measured and suggest missing links. Every suggestion stays unverified until a person accepts it.

Scoped to your device class

Class II gets the full 510(k) set; Class III adds clinical evidence; a Class I exempt device sees only the minimal records that apply.

  • Requirements, software (IEC 62304) and usability (IEC 62366) records in one place
  • Bulk import of existing requirements, brought in as unverified drafts
  • Traceability matrix export as CSV or PDF, with gaps and flagged items shown, never hidden

The submission builder

It pulls the sections it can straight from your modules, lets you import or draft the gaps, then assembles the package: the actual cover letter, IFU and comparison, ready to review. Assemble your 510(k) package and track the review. You file with FDA; we keep the record.

  • Pulls from Requirements, Risk, Test runs & DHF
  • A deterministic package-completeness check before you file (not FDA’s own acceptance screen)
  • A cybersecurity section shaped like eSTAR’s: the section 524B cyber-device questions, an SBOM reader (CycloneDX or SPDX JSON) and every attachment eSTAR asks for
  • A standards and citations list read from your records, and the whole package as one ZIP with a hash manifest (not an eSTAR)
Show 2 more
  • Draft point-by-point answers to an FDA deficiency letter that you review before anything is assembled, and a checklist of the 21 CFR Part 801 elements in your label and IFU
  • FDA user fees and a small-business check, with current fees linked from FDA

The full quality system, too

Document control with Part 11-ready sign-off and release control, training with competency quizzes, CAPA with a postmarket loop, complaint/MDR triage, suppliers, and an Audit center that generates auditor spreadsheets and a QMS state report on demand.

  • Part 11-ready records & a database-enforced audit trail
  • QMSR gap check with a tracked list of FDA regulatory changes
  • Unlimited controlled documents & records
  • A device Inbox: what’s waiting on each device, most severe first
Show 2 more
  • Upload your own SOPs and templates and draft new documents in their style; generate a starter set of SOPs and plans for a device, including the post-market surveillance plan, each a draft you review and release
  • Legal holds that block deleting, obsoleting or unlinking what they cover, and retention rules that list records past their period for you to decide on (nothing is ever deleted automatically)

Working together

  • Comment on any record, document or submission section, mention colleagues and assign follow-ups with a due date; every thread shows whether the thing it discusses is verified
  • Section-level permissions: an owner can limit who may edit or review each submission section, enforced on the server

For consultants

  • A personal library of your own templates, SOPs and snippets that you copy into any client workspace, never shared between clients
  • One review queue of every AI draft waiting across all your clients; a records-vs-procedure audit that names the clause each finding tests; complaint trends beside MAUDE and your risk file
More for consultants

Built for regulated work.

Built by a device-industry regulatory practitioner, for records you'll have to defend. The controls a quality team and a buyer's security review ask about, with honest status.

  • AI you can checkEvery AI passage carries its source and a record of who verified it. Nothing counts as done until a person signs off.In place
  • Part 11-ready recordsRe-authentication at signing, and an append-only audit trail the database enforces.In place
  • Workspace isolation enforced at the database levelEvery client's records are separate, checked twice. Encrypted in transit, and at rest by the hosting platform.In place
  • Role-based access (4 roles, 20 permissions)Plus single sign-on (OpenID Connect), an IP allow-list per workspace, and access you can end.In place
  • Design reviews with phase gates7 phases for a 510(k), 12 for a PMA. A DHF compiled from the record: 8 elements for a 510(k), 14 for a PMA.In place
  • Your data is yoursWhole-workspace and audit-trail export in standard formats, and a read-only MCP connector for Claude and other AI clients.In place
  • A QMS state report on demandIt describes your records, and is not a validation package.In place
  • SOC 2 Type II, ISO 27001 and an IQ / OQ / PQ validation packagePlanned ahead of paid pilots. Nothing here is claimed before it is in place.Planned

Status as of October 2026. Read the full trust page

The only tool that spans strategy, submission, and QMS.

Formwork drafts documents cheaply. Greenlight Guru stores them at enterprise scale. Cruxi does submission drafting without the quality system. Allele matches the incumbents on the quality system and does the FDA strategy work in between. It is straight about where it is not there yet.

CapabilityAlleleFormworkGreenlight GuruCruxi
ISO 13485 / QMSR document control●●●—
Part 11-ready e-signatures (password re-entry)●● (claims compliant)●—
Risk, software, usability (14971/62304/62366)●●●—
CAPA, complaints/MDR, training, suppliers●●●—
AI drafting and requirement checks●●●● (submission drafting)
Predicate search with recall flags and FDA sources●——●
AI output linked to exact source page and quote●—No (asks users to verify)●
Per-record provenance and human verification status●———
Class-aware pathway strategy (510(k)/PMA/exempt)●——Partial (classification)
Pre-Sub prep●———
eSTAR / submission assemblyReadiness by eSTAR section + eSTAR data file (you file)——● (18 sections)
DHF + live traceability matrix●Partial●—
Multi-client consultant workspaces and a cross-client dashboard●——Agency credits
Validation report, migration, supportPlanned●●Optional expert review
Clinical evidence (EDC)——●—
PriceFounding cohortFree; $119/mo; $599/mo~$15–60K/yr + onboarding$1,000/submission, $200/service, or $500/mo

Competitor features and prices verified September 2026 from each vendor’s published pages; confirm current details. Sources: openregulatory.com/formwork/pricing · openregulatory.com/articles/greenlight-guru-price · greenlight.guru/blog/greenlight-guru-ai-features · cruxi.ai predicate-finding, 510k-submission-services and pricing pages.

Questions, answered.

Is this an eQMS or a submission tool?
Both. Allele runs a full ISO 13485 / FDA QMSR quality system (controlled documents, sign-off and release, training, CAPA, risk, usability) and adds the regulatory strategy and FDA submission workflow that a standalone eQMS leaves to you.
Does it work for Class I, II, and III devices?
Yes. The whole workflow is class-aware: a Class II device runs the 510(k) path, Class III runs PMA, and a Class I device collapses to registration & listing. Pick a class in the explorer above to see the difference.
How does the AI stay trustworthy?
Every AI-drafted passage is tagged and stays unverified until a human reviews it, and only verified content counts toward your readiness. Where the AI reads an FDA document, the claim is linked to the page and quote it came from. The provenance and every signature are captured in an append-only audit trail that the database itself enforces, and if a suggested rewrite would drop a number or a record ID it is withheld rather than applied.
Can it actually generate my submission?
It lays your readiness out in the 16 sections of FDA’s eSTAR a 510(k) fills, answers what it can from your records, reads the lab and test reports only you hold (quoting the page each answer comes from), drafts narrative sections for your review, and exports a data file for eSTAR’s own Import Data, with your attachments. Two things it deliberately does not claim: that import has not yet been verified in eSTAR itself, and its completeness check is not FDA’s technical screening. FDA runs its own, and passing ours predicts nothing about it. Then it links out to the CDRH Portal. We transmit nothing to FDA. You file, and the app records the tracking number you were given and tracks the review clock from it.
Can I get my data out?
Yes, and in standard formats: the traceability matrix as CSV and PDF, your QMS records as CSV (a summary, or every field), and the DHF as a PDF binder, with open gaps shown and flagged rather than hidden. A workspace owner can also export the whole workspace as one ZIP: JSON, CSV, readable copies of every document revision, every uploaded file checked against its checksum, and an index to find your way around. Its complete audit trail is in it too, as CSV. Your data is never deleted because you stopped paying. Coming the other way, from another eQMS or a spreadsheet? Import CAPAs, complaints, training records and suppliers from a CSV: you see a preview of every row first, and records already here are skipped, never overwritten.
Can my client or an outside reviewer see the records?
Yes, without an account. A workspace owner creates a read-only link to one device: its verification record, classification rationale, traceability matrix and audit trail, generated fresh each time. The link expires after 7, 14 or 30 days, can be revoked at any time, and every view and download is recorded in your audit trail.
Can I try anything without an account?
Yes. The FDA classification lookup: describe a device or type its product code, and it shows FDA's own classification records (class, regulation, review panel and typical pathway). It is FDA's published classification, not a determination for your device. And the predicate search: a product code and a few words give the devices FDA has cleared under that code, ranked by name, as a starting list. Four short checks walk through FDA’s own criteria, with the guidance cited: Special 510(k), De Novo, 513(g) and Breakthrough designation. They screen; they don’t decide. And Learn has plain-language explainers on each pathway and the outlines of our quality-system templates. None of it uses AI or needs a sign-up.
Can I use it from Claude or another AI assistant?
Yes. Create a personal API token on your profile and add the read-only connector (it speaks the Model Context Protocol, MCP) to Claude or any MCP client. It reads devices, design records, documents, the submission package and quality records, and sees exactly what you can see in the app, nothing more. Each record still says whether it was AI-drafted and whether a person has verified it. The connector can’t change anything.
Does it work with Slack or Microsoft Teams?
Yes, for workspace updates: an owner connects a channel with an incoming webhook and picks what goes there, such as FDA watch alerts, guidance changes and items falling due. Each post is one line and a link back; record contents never leave the app, and anything addressed to one person stays in their own Updates.
Does it connect to Jira?
Yes. An owner connects your Jira Cloud site, and anyone who works on CAPAs and complaints can create a Jira issue from one or link an existing issue. Each linked issue’s status shows beside the record and is refreshed daily; it never closes anything here, because closing a CAPA still needs its effectiveness evidence.
Can I import documents from Google Drive?
Yes, where your workspace has it switched on: pick a Google Doc, PDF or Word file in Google’s own picker, and it’s read exactly like an upload, with each requirement it finds proposed as an AI draft for you to check. We can only see the file you pick. SharePoint and Box aren’t connected yet.
Is the tool itself validated?
Not yet, and we will not pretend otherwise. A software-validation package (IQ/OQ/PQ), the artifact a buyer’s quality team asks for, is planned and not available. The Audit center’s QMS state report describes your records; it is not that package. If you need vendor validation evidence before you can adopt a tool, tell us and we will tell you honestly where it stands.
Who's behind it?
One person: a medtech regulatory practitioner who has been through the predicate and submission process many times, at a device startup and two of the largest device companies in the world, with a biomedical-engineering background behind the science and the standards. The tool is built from how submissions actually get done, not how a generic document system imagines it. Read the story.

From predicate to cleared, in one workspace.

Bring one device, and see your pathway and submission take shape.

I'm building a device I'm a consultant
Book a demo