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41 requirements · 39 traced through to a result · 2 gaps
34 pass3 fail2 gap2 not run
Parent document
Requirement
Requirement text
Risk
Test protocol
Result
Status
UNUser Needs
UN-001
Continuously monitor heart rate over a 72 hour cycle
RISK-02
TST-101
RES-101
Pass
UNUser Needs
UN-002
Alert the user within 5 seconds of a detected arrhythmia
RISK-07
TST-104
—
Gap
UNUser Needs
UN-003
Display the most recent 24 hours of rhythm data
—
TST-106
RES-106
Pass
SRSSystem Requirements
SRS-001
Sampling rate of 256 Hz sustained across the recording window
RISK-02
TST-201
RES-201
Pass
SRSSystem Requirements
SRS-003
Arrhythmia detection latency below 5 seconds at 95th percentile
RISK-07
TST-204
RES-204
Fail
SRSSystem Requirements
SRS-004
Battery endurance of seven days under nominal load
RISK-11
TST-208
RES-208
Pass
SRSSystem Requirements
SRS-008
Companion app refresh interval no greater than 2 seconds
—
TST-212
—
Not run
SASSoftware Architecture
SAS-002
Detection pipeline isolated from the telemetry service
RISK-07
TST-301
RES-301
Pass
TraceableVital Cardio Sensor›System RequirementsSaved just nowv2.0Awaiting signatureSignAD
Publishing is gated. 2 of 4 signatures captured, all comments resolved.
8. Approval and signatures
By signing below each approver confirms that they have reviewed this revision in full and that it is fit for release under the project quality plan.
Signature Table
Role
Name
Title / Position
Signature
Contributor
Aria Demir
Lead Author
✓ Signed digitally22 Aug 2026, 18:28I have reviewed this document in my capacity as Contributor.sig 8f3a1c72-4e05-4b91-a6d3-7c2e9b58d140
Lead Author
Reza Farhadi
Systems Engineer
✓ Signed digitally22 Aug 2026, 19:05Technical content verified against the design inputs.sig 2d90b64f-71ac-42e8-9f15-0ab3c6d82e57
Reviewer
Mei Chen
Quality Engineer
Sign
Approver
Kenji Nakamura
Quality Manager
SignApprover signs last — 1 prerequisite signature still required.
Each signature records the signer’s identity, the revision hash and a server timestamp against the GUID shown. Signatures are void if the revision changes.
TraceableMeridian Medical›Vital Cardio Sensor›Risk Management FileSaved 4 min agov1.4In reviewEdit−100%+
Meridian Medical · Vital Cardio Sensor
Risk Management File
RISK-DOC-001 · 18 Aug 2026 · Aria Demir
7. Referenced documents
Risk acceptability is assessed against ISO 14971:2019 [2]. Detection latency requirements are carried in D0067 [5], with measured performance recorded in RPT-2026-014 [6].
References
#
Number
Name
Version
[1]
ISO 13485:2016
Quality management systems for medical devices
v2
[2]
ISO 14971:2019
Application of risk management to medical devices
v1
[3]
IEC 62304:2006+A1:2015
Medical device software life cycle processes
v2
[4]
SOP-QMS-014
Risk Management Procedure
v3.0
[5]
D0067
Software Requirements Specification
v0.3
[6]
RPT-2026-014
Detection latency bench report
v2
Needs attentionD0067 is not at a published version. It is cited at v0.3, a draft, so this file cannot be issued until the reference moves to a release.
1
Authoring
Why use Traceable?
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Here is what slows regulated teams down, and what changes when the work lives in one place.
Holding you back
01
Files were never meant to manage a live design
“Keep it simple” is a good rule, but a product worth certifying is not simple. Files are passive: they cannot link a requirement to the test that proves it, version themselves, or show you the state of the whole design.
02
Every step in the flow adds another tool
Count them. From the first requirement to a formal release: template, document number, folder, authoring, review, export, publish, then a design change and around again. Every hop is somewhere work gets duplicated, delayed or lost.
03
Every role needs something different, and now so does AI
Engineering, quality, regulatory and approvers each need something different from the same document, and AI now drafts alongside them. The certifier still has to sign it off. One tool has to serve all of them and stay audit ready.
The solution
Live traceability that can’t silently break
Every requirement is linked, and those links stay valid as the design changes. Versioning is automatic, and the whole design stays visible in the traceability matrix and the document map.
One workspace, first draft to signed release
Start from templates built for the standards you work to. Numbering, authoring, review, approval and publishing all happen in one place, so there is no flow to map across tools and nothing to re-key.
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Requirements, risks and tests stay connected as documents change, and a broken link surfaces before an auditor finds it.
ID
Requirement
Type
SRS-001
Delivery accuracy within ±5%
Functional
SRS-003
Alarm raised on interrupt
Safety
SRS-004
Endurance of seven days
Performance
Add row
05
Structured content
Requirements, risks and tests are data you can filter, link and report on, not paragraphs to search through.
Meridian Medical · Vital Cardio Sensor
User Needs
RevDateChange
1.102 AprTolerance revised
1.225 AprAlarm timing
Locked PDF
06
Immutable snapshots
Every publish captures a locked PDF snapshot, so you always have the exact document that was approved.
How it works
From blank page to audit-ready, in one controlled flow.
Author, trace, control, review and publish. Each step hands the next one everything it needs.
Available now · Release 1
01
Author
Write in a structured canvas from templates for the standards you work to: text, tables and requirement grids, not loose prose.
TemplatesAuto-save
02
Trace
Give every requirement a TraceID and link it across documents. Coverage stays live in the matrix and the document map.
TraceIDsRTM
03
Control
Every draft keeps a row-level change log with comments and mentions, under a published, draft and fix version model.
Change logComments
04
Review & sign
Nothing publishes until comments are resolved and e-signatures are captured, each with the signer’s identity and a timestamp.
e-SignaturesGated release
05
Publish
Each release locks an immutable PDF snapshot and generates the revision table from the document’s own published history.
PDF snapshotRevision table
Built for regulated industries
Compliance, by design.
Traceable maps directly to the standards your industry requires, so audits become an export, not a project.
IEC 62304 · Medical device software lifecycle
ISO 13485 · Medical device QMS
ISO 14971 · Risk management
ASPICE · Automotive SPICE
21 CFR 820 · FDA Quality System
21 CFR 11 · Electronic records & signatures
DO-178C · Airborne software
MIL-STD-882E · System safety
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