Your ISO 13485 records in Jira and Confluence.
Controlled documents, training records, CAPA and IEC 62304 software testing with signed evidence, where your engineers already work. Built on Atlassian Forge: your quality and design records stay in your Atlassian site.
Your QMS records, next to your design work.
Each app works on its own, on your existing pages and work items. Start with what your next audit will sample.
- Clearlane Controlled Documents
Control your documents
Approval by named approvers with e-signatures, effective revision, periodic review, edits after approval flagged, obsolete documents kept.
- Clearlane Read & Understood
Keep training current
Read confirmations per person and page version, with optional questions and signature. A new version asks people again.
- Clearlane CAPA
Run CAPA
From any Jira work item (complaint, nonconformity, audit finding): root cause, signed plan, actions in Jira, effectiveness check, signed closure.
- Clearlane Tests
Test your software
Test cases linked to requirement work items, signed runs and closures, a bug from a failed step in one click, coverage per requirement and a PDF report.
Requirement, what the app does, your part.
The detail for each standard, with OQ scripts, is on our validation support page.
| Requirement | What Clearlane does | Your part |
|---|---|---|
| ISO 13485 4.2.4 Control of documents | Controlled Documents: review and approval with e-signatures, current revision shown, changes after approval flagged, periodic review, obsolete documents kept with their history. | Write the procedures, name the approvers, set review periods. |
| ISO 13485 4.2.5 Control of records | PDF evidence files and CSV exports; records kept in Atlassian’s storage for your site with an audit trail. | Set retention (at least the lifetime of the device, and no less than two years) and archive the PDFs. |
| ISO 13485 6.2 Human resources: competence and training | Read & Understood: confirmation per person and page version, optional comprehension questions, records by person. | Define training needs, assess effectiveness and keep other evidence of competence. |
| ISO 13485 8.3 Nonconforming product, 8.5.2 Corrective action | CAPA: any work item can become a CAPA, guided root cause, signed plan, actions as linked work items, dated effectiveness check, signed closure. | Investigate, decide the actions and assess their effectiveness and impact on safety and performance. |
| ISO 13485 7.3.6 Design verification; IEC 62304 5.7 Software system testing | Tests: test cases with steps and expected results linked to requirements, runs recording result, tester, date and case version, signed closure, PDF report. | Define pass/fail criteria, the build tested and test configurations, and evaluate the results. |
| Traceability of requirements to tests (IEC 62304) | Tests: the Coverage tab lists each requirement with its test cases and their results (passed, failed, not run, not covered), with a CSV export. | Keep the links current and keep the exports you need as records. |
| IEC 62304 9 Software problem resolution | Tests: a failed step becomes a Jira bug in one click, with steps to reproduce, expected and actual result, linked to the requirement. | Run the rest of your problem resolution process in Jira. |
| ISO 13485 4.1.6 Validation of QMS software; 7.4.1 Supplier evaluation | OQ test scripts, requirement mappings and a supplier assessment form on our validation support page. | Validate each app for its intended use, proportionate to the risk. |
| 21 CFR Part 11 Electronic records and signatures | Personal signing password at each signature, name, date and meaning, SHA-256 fingerprint of the signed content, audit trail. | Write the signature policy and send the certification letter to the FDA. |
References are given to help you find the relevant requirement, not as a claim of compliance.
Signed PDFs your auditor can sample.
Document evidence file
Signatures with name, date, meaning and fingerprint, revisions, read confirmations and the audit trail.
Training record
Who confirmed which version and when, with tries and signature IDs.
CAPA evidence file
The six steps, signatures, attachments and the audit trail.
Test campaign report
Results by step, bugs, signatures with fingerprints and requirement coverage.
Questions, answered.
- Do the apps replace a medical device eQMS?
- For teams that already work in Jira and Confluence, they cover document control, training records, CAPA and software testing. They do not assemble a design history file, a risk management file (ISO 14971), complaint handling with vigilance reporting, or UDI data.
- How do we show IEC 62304 traceability?
- Link test cases to your requirement work items. The Coverage tab lists each requirement with its test cases and their latest results, exports it as CSV, and each campaign’s PDF report includes the coverage of its requirements.
- Is Clearlane CRA for medical devices?
- No. The Cyber Resilience Act does not apply to devices covered by the Medical Device Regulation or the In Vitro Diagnostic Regulation (Article 2(2)). Use CAPA and Tests for your software problems and verification. Products of yours that are not covered by the MDR or IVDR may still be in scope.
- Can we start with one team?
- Yes. Controlled Documents, Read & Understood and Tests are free for up to 10 users, and CAPA starts at $10 a month: the quality team can start with document control, and the software team with Tests.
Start with the record your next audit samples.
Controlled Documents, Read & Understood and Tests are free for up to 10 users. No setup, nothing to install outside your Atlassian site.