Quality
Procedures, work instructions, audits and CAPAs as controlled blocks with revisions, review and release. The handbook assembles them into one readable manual.
Every requirement, risk and record on one thread
Unravel is the quality management system for medical device teams. Documents, design controls, risk, training and e-signatures live in one workspace and link to each other, so the trace an auditor asks for already exists.
Catalogue requirements for
- ISO 13485
- ISO 14971
- IEC 62304
- ISO 9001
- 21 CFR Part 11
01 · The Ravel
Everything is a block, and blocks link
A requirement, a risk, a test, a procedure, a training record: each one is a block with an owner, a revision and a state. Link them once, and the trace matrix, the coverage gaps and the graph of your whole system follow from those links.
RequirementRiskVerificationState
REQ-014Alarm sounds when SpO₂ drops below the set limitRSK-007VER-031Released
REQ-015Limit can be set between 85 and 95 %RSK-007VER-032Released
REQ-021Reading stays stable during patient movementRSK-011VER-040In review
REQ-022Battery warning 30 min before shutdownRSK-013MissingDraft
02 · Modules
Turn on the parts of the system you run
Each workspace enables only the modules it needs. They share one permission model, one search and one audit trail.
Design
Design inputs, outputs, risks and verifications linked block to block. The trace matrix and The Ravel graph show what is covered and what is still open.
Training
Assign procedures to roles, track who has read which revision, and see gaps in the training matrix.
KPIs
Quality objectives with targets, measured from the records you already keep.
Assets
Equipment with service records and due dates, so calibration never slips past an audit.
Projects
Projects, milestones and tasks next to the design records they produce.
Company
Customers, employees and job roles. Roles drive permissions and training at the same time.
03 · Electronic signatures
Part 11 signatures, not a checkbox
Approvals are signed with a separate signing password and bound to the signer, their role and the exact revision. Every challenge, signature and rejection lands on the block's timeline, and signed records cannot be deleted.
- 11.50 Meaning, signer name and UTC time on every signature
- 11.70 Record and signature hashed together, so they stay linked
- 11.10(e) Challenge and commit events in the audit trail
SOP-003 · Rev CReleased
Handling of customer complaints
- Author
- Jonas Weber · 2026-11-03 09:12 UTC
- Approver
- Anna Becker · 2026-11-03 14:22 UTC
- Meaning
- Approval of revision C
- Record hash
- 3f9a 61c0 a8e2 7b14
04 · Coco
An assistant that drafts and waits for you
Ask Coco about your workspaces, or have it draft a new block or a change to an existing one. Nothing is written until you approve it, and Coco only sees what you are allowed to see.
You
Which design inputs for PX-2 still have no verification?
CocoOne: REQ-022, the battery warning. I drafted VER-041 for it. Review the draft?
05 · Configuration
Shaped to your QMS, not the other way round
Catalogue
Ready-made regulatory requirements to import, so a new workspace starts from a structure instead of a blank page.
Block library
Templates for the most common records. Import one and it is ready to use.
Block designer
Your own record types with your own fields, when the library does not have what you need.
PDF templates
Exports on your letterhead with your document control fields.
06 · Services
We help you move in
01
Setup
We configure workspaces, modules and roles with you, and import the catalogue entries for the standards you work to.
02
Migration
Existing procedures and records move over as blocks, with their history and links instead of as attachments.
03
Validation support
Documentation for your computer system validation, including the Part 11 control mapping.
See your own system on one thread
We walk you through Unravel with your processes and standards in mind.