Qualmitta is an end-to-end SaaS platform for medtech and pharma teams — draft 510(k), PMA, IND, NDA, ANDA, CMC and EU MDR dossiers, mine live openFDA intelligence, and run post-market surveillance from a single project workspace. One system of record for every submission.
Chuck is Qualmitta's in-house language model, specialized for FDA and EU MDR workflows. It learns from expert-graded regulatory drafts, curated guidance corpora, and structured knowledge from openFDA, USPTO, and eCFR. Today Chuck runs alongside Claude Sonnet 4.5 — over time, more of your workspace will be served by Chuck directly.
Try Chuck in the workspaceNothing you draft trains Chuck unless you turn it on in your workspace settings. It is off by default for individual accounts and excluded by default for Enterprise tenants.
Contributions are aggregated, de-identified, and stripped of proprietary device names, patient data, and confidential identifiers before ever reaching a training corpus.
We do not share your inputs, outputs, or drafts with third-party model providers for their training. Claude sees only per-session context under Anthropic's zero-retention API terms.
Enterprise workspaces are excluded from Chuck training pipelines unless a program owner explicitly opts in. Full data-use logs are available on request as part of an Enterprise agreement.
Purpose-built for RA, QA, R&D, clinical, and consulting teams shipping Class I / II / III devices and CDER-regulated drugs.
Structured drafting for the entire premarket dossier — device and drug — with 21 CFR / ICH section maps, substantial-equivalence tables, and inline citations. Every draft is a working artifact your team can edit, redline, and export.
Ask 21 CFR 820, ISO 14971, IEC 62304, ICH Q8-Q11, or a specific guidance document. Answers stream back grounded in your device or drug context, with citations you can trace to source.
Semantic scoring across openFDA's live 510(k) database and Reference Listed Drugs. Save predicate sets per project, generate side-by-side substantial-equivalence write-ups in seconds.
17M+ device MDR reports and 20M+ drug FAERS events — pulled live per device family or drug class. Get synthesized failure-mode briefs and risk signals you can hand to your PMS lead.
USPTO ODP-backed screening surfaces overlapping US patents, generates an FTO briefing, and recommends concrete design-arounds. Screening only — a registered patent attorney signs off on the opinion.
500K+ studies on ClinicalTrials.gov, full Prescribing Information via openFDA, and Module 3 CMC scaffolding grounded in ICH M4Q — search evidence you can cite in a CER, IND, or ANDA.
Bundle every artifact for a device or drug into one project. Invite RA specialists, QA leads, quality engineers, and clinical writers. Track cited-regulation freshness against eCFR. One-click submission-package PDF.
FDA's 2017 change-control decision tree applied to any change. Letter-to-File vs. Special 510(k) recommendation with rationale and DHF documentation checklist.
Full CDER coverage: 21 CFR 312 IND, NDA, ANDA, Prescribing Information per 21 CFR 201.57, Module 3 CMC per ICH M4Q, OTC monograph work. Grounded in openFDA RLD, FAERS, and label data.
Draft submissions, own the citations, ship faster.
Get from concept to premarket path without an in-house RA team.
Design Controls, DHF, CAPA, and audit-ready QMS scaffolding.
Turn requirements into DHF, risk files, and V&V plans.
CERs, PMCF plans, IND CMC narratives — evidence-grounded.
Handle 3× the client load with one shared workspace per program.
Qualmitta structures every artifact to the exact FDA / ICH / EU MDR section requirements, cites regulations inline, and exports to PDF or DOCX — with full version history and reviewer redlines built in.
Qualmitta cites and cross-references against the same primary sources FDA and Notified Body reviewers use. Every regulation reference is a live link to eCFR — no hallucinated CFR sections, no stale citations.