🏥 Industry · Medical Device Manufacturing
Your production floor is running.
But is every stage of your DHR documented and complete?
From component receipt to dispatch — full batch traceability across every medical device production stage. Track assembly, sterilisation, QC, labelling, and documentation with complete Device History Record visibility.
Medical device manufacturers — full DHR traceability live
As featured in PrintWeek India, April 2026
Your Production Flow
Every batch. Every stage. Every DHR entry tracked.
This is how a print job moves through your business. Clicarity gives you live visibility at every phase — and flags delays before they become client calls.
01
Component Receipt & Incoming QC
4 stages
Purchase Order & Component Receipt
All components received per approved BOM with certs and COAs.
✓ Clicarity: Lot number and supplier cert recorded — full traceability chain begins
Incoming QC
All components tested against approved specifications.
⚠ ⚠ Common delay: incoming failure — production hold while supplier resolves
Quarantine Release
Components released from quarantine after QC approval.
✓ Clicarity: Release logged with QC sign-off — components cannot enter production without
Component Issuance
Approved components issued to production per batch BOM.
✓ Clicarity: Issued quantities logged — batch BOM accountability begins
02
Assembly & Sub-Assembly
4 stages
Sub-Assembly
Sub-components assembled per approved work instructions.
✓ Clicarity: Operator ID and work instruction version logged per sub-assembly
Final Assembly
Device fully assembled per device master record.
✓ Clicarity: Assembly checklist confirmed — no step skipped without sign-off
In-Process Inspection
Critical assembly checkpoints verified per control plan.
⚠ ⚠ Common delay: non-conformance at in-process check — batch held for disposition
Functional Testing
Device tested for specified performance parameters.
✓ Clicarity: Test result logged per unit or batch — non-conforming units tracked
03
Sterilisation & Validation
3 stages
Pre-Sterilisation QC
Final visual and dimensional inspection before sterilisation.
✓ Clicarity: Pre-sterilisation acceptance confirmation — batch cannot proceed without
Sterilisation
Batch sterilised per validated process — EO, gamma, or autoclave.
✓ Clicarity: Sterilisation cycle parameters, date, and PCD result logged per batch
Sterilisation Release
Batch released after sterility assurance confirmed.
⚠ ⚠ Common delay: parametric release delayed — batch in quarantine, customer order waiting
04
Labelling, QA Release & Dispatch
3 stages
Labelling & Coding
Approved labels applied — device name, lot number, expiry, UDI.
⚠ ⚠ Common delay: label version not approved — batch held for correction
QA Final Release
Complete DHR reviewed and batch released by QA.
✓ Clicarity: DHR completeness automatically verified — dispatch blocked without sign-off
Dispatch
Batch dispatched with full documentation — COA, sterilisation cert, DHR reference.
✓ Clicarity: Full lot traceability from component receipt to dispatch preserved
Where Medical Device Manufacturers Lose Compliance & Time
Real bottlenecks. Real costs. Real fixes.
These are the patterns Clicarity helps businesses identify and fix within the first few weeks.
Audit Preparation
Audit preparation taking 1 week — manual DHR compilation across departments
A medical device manufacturer spent a full week before each regulatory audit compiling batch records from multiple departments. Records were in different formats, different locations — paper registers, Excel files, lab notebooks. With Clicarity, the DHR builds automatically at every stage. Audit preparation time reduced from 1 week to 4 hours.
Audit preparation reduced from 1 week to 4 hours
Sterilisation Quarantine
Batch in sterilisation quarantine 18 days — customer delivery missed
A sterilisation release was delayed because parametric release documentation was not compiled on time. Batch sat in quarantine 18 days — customer order missed. With Clicarity, sterilisation documentation is a tracked stage that begins during the cycle. Release preparation starts automatically. Quarantine-to-release time reduced from 18 days to 3 days.
Sterilisation quarantine time reduced from 18 to 3 days
Label Error
Wrong label version applied — entire batch relabelled at ₹38,000 cost
A labelling team used a label version that had been superseded by a regulatory update. Entire batch required relabelling — ₹38,000 in labour and material. With Clicarity, labelling requires label version confirmation against the current approved version before application. Label version errors: eliminated.
₹38,000 relabelling cost prevented — label version confirmation enforced
Real Printing Business. Real Results.
""FDA audit readiness used to mean a week of manual record compilation before every audit. Now the DHR is built automatically as production progresses. Audit preparation time: 4 hours.""
What improves in medical device businesses using Clicarity
↓ 85%
Audit preparation time
100%
DHR completeness at dispatch
↓ 50%
CAPA resolution time
5 days
To go live — full setup included
One licence. Your entire operation.
No per-user fees. Full setup by the Clicarity team. Live in 5 days.
Single Licence
₹30,000
/ year
1 user · Annual licence
₹82 a day. Less than a daily meal for one person — for your entire team's visibility, all year.
Get a Quote
Multi Licence
₹55,000
/ year
Unlimited users · Annual licence
₹150 a day. Less than the cost of one missed delivery — for full visibility across your entire team.
Get a Quote
Annual billing · No hidden fees · Full setup included · Go live in 5 days
Questions from medical devices businesses
How does Clicarity work for a printing business specifically?
Clicarity is configured around your specific print workflow — pre-press, printing, finishing, dispatch — in your terminology. Every job gets a unique ID and moves through your defined stages. You see live status, timestamps, and bottleneck alerts at every stage. The Clicarity team builds everything for you. You go live in 5 days.
Does it work for both offset and digital printing?
Yes. Clicarity works for any print process — offset, digital, wide format, screen printing, or a combination. The stages are configured around your actual workflow. If offset jobs go through plate making and digital jobs skip that stage, both can be tracked correctly under the same system.
Can it track material wastage at each stage?
Yes — with the Multi Licence. At every stage, your team logs quantity in and quantity out. Clicarity calculates the loss automatically. You see wastage by stage, by job, live — not at month-end when nothing can be done about it.
Will my press operators actually use it?
Yes. The update screen has two fields — Job ID and status. Under a minute. No training needed. GP Offset's entire team was using it from day one, including floor workers who had never used a software system before.
Full DHR. Every batch. Audit-ready at any time.
Book a free demo. We'll map your medical device workflow live on the call.
No commitment
Live in 5 days
Annual licence
Full setup included