Core
Clause Mapper
Auto-link every SOP, record, and DHF artifact to ISO 13485, FDA QSR, and MDR clauses. See coverage, gaps, and stale evidence in one view.
Move from spreadsheet chaos to audit readiness in 48 hours. Built for ISO 13485:2016 and FDA 21 CFR Part 820 compliance.
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Analyze your DHF in seconds. Clausewell maps your existing documents against ISO 13485:2016 to show your real-time compliance gaps.
Standards supported
The 48-hour transformation
Brittle spreadsheets, broken cross-references, signatures stuck in inboxes.
A single, traceable system of record. Every artifact mapped, signed, and time-stamped.
The problem
Six weeks of nights and weekends to assemble what should already exist. Clausewell keeps you inspection-ready every day, so audit week is just another Tuesday.
CAPA_log_FINAL_v7_USE_THIS.xlsx is not a quality system. Replace fragile, unvalidated spreadsheets with a controlled, traceable record that satisfies ISO 13485:2016 Clause 4.1.6 software validation.
Nonconformities slip through because no one was watching the trend. Automated CAPA triggers escalate root-cause analysis the moment thresholds breach — closing the loop ISO 13485 Clause 8.5.2 demands.
Manual clause mapping and evidence hunting consume 30–40% of QA capacity. AI does the lookup; your team does the engineering.
The toolkit
Built with QA leaders from Class II and Class III device companies. Every module is opinionated, traceable, and exportable.
Auto-link every SOP, record, and DHF artifact to ISO 13485, FDA QSR, and MDR clauses. See coverage, gaps, and stale evidence in one view.
A trained agent reviews your QMS the way a notified body would. Receives plain-English findings with citations to the exact clause and document line.
A single defensible source of truth. Versioned, time-stamped, Part 11 compatible. Export an audit binder in one click.
A continuously calculated score with the exact actions to raise it. No more guessing whether you're ready for the unannounced visit.
Edit one SOP and instantly see every linked record, training, and clause that needs review. Stop silent regressions before they ship.
Simulate an FDA inspection or notified body visit. The toolkit runs the questions; you practice the answers — with your real evidence.
How it works
Upload your existing Quality Manuals or spreadsheets via our encrypted gateway. Source documents are never altered.
Our engine maps your documentation against ISO 13485 and FDA 21 CFR Part 820 requirements to identify missing controls — with citations.
Receive a serialized, compliant QMS structure ready for notified body review within 48 hours.
Trust by design
Clausewell is engineered by people who have shipped Class II and Class III devices and survived the audits that follow. Every output is traceable, every change is logged, every model decision is explainable.
“We used to spend six weeks preparing for a notified body visit. With Clausewell, the evidence is already assembled — we spend that time on engineering instead.”
Early access
Join the medical device QA leaders piloting Clausewell. Onboarding in under a week. White-glove migration from your existing QMS.
Join 15+ MedTech founders currently in our early-access pilot.
We respond personally to every request within 48 hours.
AES-256 encryption, SOC 2 compliant infrastructure, and private data silos for every MedTech client.