MedTech Product Lifecycle Management

Device requirements, risks and evidence

Connect requirements, design outputs, verification and changes in one device record.

Every requirement traced to its risk and test Risk file on your ISO 14971 process UKCA and CE packs from one record

Device lifecycle workspace on DeX

Trace matrix live Example data

Product home

Status of one device

Wearable ECG patch WP-1 · Class IIaUKCA + CE

Define

Design inputs

Risk

Design & build

Verify & validate

Gate review

Release

7Open gaps

3Pending approvals

142Linked records

Recent changes

CR-014 · Adhesive supplier changeIn review

TP-031 results attachedLinked

Requirement tree

Linked to SR-01.1

CoveredIn progressGap

Need	Requirement	Risk control	Test	Status
UN-01	SR-01.1 Battery life	RC-04 Low-battery warning	TP-031	Covered
UN-01	SR-01.2 Adhesion	RC-07 Skin-safe adhesive	No test linked	Gap
UN-02	SR-02.1 Alert latency	RC-02 Watchdog timer	TP-018	In progress
UN-02	SR-02.2 Alert delivery	No control linked	TP-019	Gap
UN-03	SR-03.1 Data encryption	RC-11 Encrypted transfer	TP-040	Covered

Generated from the links, so it never needs rebuilding before an audit.

Hazard	Severity	Probability	Controls	Residual risk	Links
H-03 Missed arrhythmiaSignal loss during wear	S4	P3	RC-02, RC-07	Acceptable	SR-01.2 TP-018
H-05 Skin irritationAdhesive reaction	S2	P4	RC-07	Review	SR-01.2 Test needed
H-08 Battery depletionUnannounced shutdown	S3	P1	RC-04	Acceptable	SR-01.1 TP-031

Hazard log and controls aligned to the manufacturer's ISO 14971 process.

Gate 4 · Verification and validation · checklist

All requirements linked to a test
Risk controls verified
!Outstanding: SR-01.2 adhesion test not linked
Usability summary attached

Reviewers

LML. Morgan · Head of R&DSigned

DOD. Okafor · Head of QualitySigned

RSR. Shah · Regulatory affairsPending

Stage open. It locks when every reviewer has signed.

CR-014 · Description

Replace the skin adhesive with an equivalent from a second approved supplier to remove a single-source risk.

AI impact listDrafted by agent

Requirements 2

SR-01.2SR-04.1

Risks 2

H-05RC-07

Tests 3

TP-022TP-027TP-044

Documents 4

BOM-WP1SUP-12IFU-01TF-6.2

Approval route

Impact assessment draftedDone
Design engineer reviewDone
3Quality engineer approvalNow
4Regulatory assessmentNext
5Update all affected records in one passAfter approval

Completeness

82%UKCA pack

Source records

RequirementsRisk fileTest resultsDesign outputsApprovals

Why traceability breaks

The trace gets rebuilt before every audit

Auditors want every requirement traced through to a test. Most small and mid-sized manufacturers piece that together by hand.

What every audit asks you to prove, through every change RequirementRisk controlDesign outputTest result

TodayWith DeX

Design historyRequirements in documents, risks in spreadsheets, drawings in PDM, approvals in email.One linked record per device.

Trace matrixKept by hand. Out of date by the next audit.Generated from the links, with gaps flagged.

Change controlDays of searching to see what a change touches.Every affected item listed before approval.

Technical fileAssembled at submission, delaying market entry.Built on demand from current records.

UKCA and CESame evidence, packaged differently for each route.Market-specific packs from one record.

ToolingEnterprise PLM and eQMS cost too much for a few products.Built to your procedure. Your CAD and PDM stay.

Field feedbackComplaints never reach the design team in a usable form.Post-market findings feed the next design cycle.

What DeX does

Record maintenance and design review

A device lifecycle workspace built on DeX, set up to your design control procedure.

DeX agents

Keeping the record joined up

They link each record as it's added, flag anything missing, and work out what a change will touch before anyone approves it.

Your engineers and quality team

Approve every stage

E-sign at each design gate. Your CAD, PDM and document stores stay in place, connected by integration.

LinkedRequirements

LinkedRisks

LinkedDesign outputs

LinkedVerification

LinkedApprovals

LinkedChanges

From idea to release

Follow a device record through design and release

Select a stage to see the records and reviewer roles involved.

Device record: Wearable ECG patch WP-1Example

Record completeness

What's included

Design control sized for a handful of products

Link

Linked item model

Needs, requirements, risks, outputs, tests and documents, all connected.

Live trace matrix

Generated from the links. Gaps highlighted.

Control

Risk management file

Hazards and controls on your ISO 14971 process.

Stage gates

Your phases, checklists, reviewers and e-sign.

Change

Change impact analysis

Agent lists what a change touches and drafts the assessment.

Technical file assembly

The file and market packs, built from current records.

Document

Document control

Versioning, review, approval and controlled release.

Supplier records

Approved suppliers, component changes and their knock-on impact.

Connect

Integrations

CAD or PDM, ERP, test systems and the DeX post-market hub.

Audit trail

Who changed what, when and why. Role-based access.

Who it's for

Built for teams heading to submission

Daily users

R&D and design engineersSystems engineersQuality engineersRegulatory affairs

Contributors

Manufacturing and operationsSupply chainClinical and usability

Decision makers

CTO or Head of R&DHead of QualityProgramme managers

External

Approved and notified bodiesContract manufacturersKey suppliers

Best fit

Device makers with a handful of products

Device start-ups and scale-ups

Spin-outs approaching first submission

Established SMEs on ageing paper systems

Contract design and manufacturing firms