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A cleanroom final-assembly bench with a display module in a machined white fixture and gloved hands entering the frame

Industry · Groups C and D · four supplier sites · Shenzhen

Medical devices & diagnostics

Change one component in year three and somebody has to tell you, then revalidate it. That is the part a supplier's certificate never covers.

Send us your device spec How we check a claim
Quality system
13485
ISO 13485:2016 is the medical-device QMS gate, and it is not a marketing authorisation
Class 3 premium
20–40%
Added cost over Class 2 acceptance criteria, with 8–15% expected defect rates
Cleanroom line
1000
Class 1000 cleanroom for display-module assembly, with 100% powered-on test
Traceability depth
Lot
Batch QR traceability from cell lot to finished module, on ERP records

01Pain points · what decides the programme

Four things a medical programme cannot absorb.

QMSR 2026-02-021.56 µg/cm²IPC-A-610J

Including one correction, because the most common sentence on a supplier page is also the wrong one.

01
Finished medical diagnostic equipment: a compact benchtop analyser and a slim patient monitor with blank screens
ISO 13485 is a gate, not an approval The FDA states it will not require and will not issue ISO 13485 certificates. Its QMSR takes effect 2 February 2026; 510(k), PMA or MDR clearance is still required to market. FDA
02
Two sets of hands over a shared technical document on a pale desk
Change control is the expensive part Any material, process or site change has to be notified and revalidated. The window belongs in the purchase order, not in a deviation negotiation. ISO 13485 §7.3.9
03
A technical scope document beside a board sample on a pale bench under even light
Cleanliness and traceability are measurable Ionic contamination limits are 1.56 µg NaCl eq./cm² at Class 2 and 0.78 at Class 3. IPC process limits
04
A close macro view of an impedance-controlled board cut edge under laboratory light, held in a plain black fixture
The standard is routinely misquoted IPC-A-610J, Rev J, March 2024, states in its own scope that it provides no cross-section or X-ray criteria, and there is no such thing as Class 3 certification. IPC
Related PCB fabrication & PCBA Group C register

02Technical requirements · written into the spec

The class is yours to set. Name it in the PO.

IPC-A-610JJ-STD-001JIPC-6012FIPC-7095

IPC's own rule puts the product-class decision on the user, so it belongs in your purchase order rather than a supplier's brochure.

The documents that govern a regulated build
DocumentWhat it governsWhat it does not cover
IPC-A-610JAcceptability, Rev J, March 2024, 430 ppIts scope excludes cross-section and X-ray criteria, so a visual-only claim is incomplete.
J-STD-001JSoldering process and materials, Rev J, March 2024, 116 ppAcceptance. A supplier quoting only this document has quoted half a requirement.
IPC-6012FRigid board qualification and performanceAppearance, which is IPC-A-600M, Rev M, May 2025, 212 pp.
IPC-6013FFlexible and rigid-flex boards, released 25 August 2026Rigid-board performance, which stays with 6012.
IPC-7711/7721DRework and repair, Rev D, December 2023, 286 ppSome Class 3 joints may not be reworked at all, so agree the disposition path in advance.
IPC-7095Void judgement on ball-grid and bottom-termination partsYour specification, which sets the acceptance limit the X-ray is judged against.
A technical scope document beside a board sample on a pale bench under even light
Fig. 01Inspection coverage is a specification, not a promise. X-ray void judgement, cross-section on test coupons where Class 3 applies, contamination testing and functional test.
A technical scope document beside a board sample on a pale bench under even light
Fig. 02Scope is the sentence under the code. Two sites can hold the same quality-system code and cover different processes with it.
01
A production panel of identical printed circuit boards held in a white inspection fixture
Cross-section sits outside A-610 Where Class 3 applies, coupon cross-sections are a separate inspection requirement agreed in the purchase order.
02
Digital calipers closed around a machined aluminium housing beside a blank inspection checklist
X-ray void limits are yours Void judgement methods come from IPC-7095, and the acceptance limit is the one your specification sets.
03
Digital calipers closed around a machined aluminium housing beside a blank inspection checklist
Functional test needs your fixture A generic test proves the assembly powers up. Your fixture is what proves the device works.
04
Two sets of hands over a shared technical document on a pale desk
The file is part of the deliverable Test records, deviation notes and traceability depth are agreed before production and handed over with the goods.

03Connection layer · what we supply

Four sites, and what a reviewer will ask about each.

Groups C + D · 4 sitesEach independently operated

ISO 13485 appears here as a quality management system, never as product approval.

04Trust layer · standards that apply

What each code covers, and where the claim stops.

No holder namesNo certificate numbersNo bare CE claim
01
A cleanroom final-assembly bench with a display module in a machined white fixture
ISO 13485:2016 is the quality system Design control, risk management, traceability, cleanroom, sterilisation and regulatory compliance. It is explicitly not a marketing authorisation.
02
A close view down one SMT line, with pick-and-place heads and feeder reels in strict alignment
ISO 9001 is mid-transition The sixth edition publishes on 16 September 2026 and the 2015 edition is withdrawn the same day. A 2026 report quoting 2015 is in transition or already out of date.
03
A production panel of identical printed circuit boards held in a white inspection fixture
UL status must be stated precisely Recognized Component is not UL Listed, and a build made from Recognized components is not thereby a Listed product. A CB certificate is an input to national approvals, not the approval.
04
Digital calipers closed around a machined aluminium housing beside a blank inspection checklist
CE on a medical device is a declaration A declaration of conformity under the applicable regulation, with a technical file and, where the class requires it, a notified body. Never a certificate.
05
An overlapping fan of finished TFT and OLED display modules with blank grey fields and ribbon tails
Substances: RoHS restricts, REACH informs RoHS restricts ten substances, cadmium at 0.01% and the rest at 0.1% in homogeneous materials. REACH has no mark: above 0.1% w/w the buyer must be informed.
06
Finished medical diagnostic equipment: a compact benchtop analyser and a slim patient monitor
Coverage, counted rather than claimed Of the 24 partner sites, 12 list ISO 9001, 15 list RoHS and 15 list CE, read on 13 September 2026. The trading company holds no citable certificate of its own.

05Programme archetype · anonymised

Three shapes of programme, no names attached.

Class 3 criteriaClass 1000 cleanroom10-year supply option
A
A close view down one SMT line, with pick-and-place heads and feeder reels in strict alignment
Diagnostics module A PCBA programme specified to Class 3 acceptance criteria with J-STD-001J process control, at a site publishing ISO 13485:2016 and 99.7% first-pass yield.
B
An overlapping fan of finished TFT and OLED display modules with blank grey fields and ribbon tails
Instrument display Modules from 0.96″ to 15.6″ at 300–5,000 nits, assembled on a six-station line under a Class 1000 cleanroom with 100% powered-on test.
C
A cleanroom final-assembly bench with a display module in a machined white fixture
Long-life platform End-of-life warnings 12 months ahead and a 10-year supply guarantee option, so the last-time-buy is planned rather than discovered.

06Programme archetype · how to read them

Archetypes, not references.

Published capability dataNo customer namedNo clinical claim
01
A technical scope document beside a board sample on a pale bench under even light
Where the numbers come from Every figure is a published capability number for a Group C or D site, not a company statistic.
02
Digital calipers closed around a machined aluminium housing beside a blank inspection checklist
What is not claimed No customer is named, no clinical or regulatory outcome is claimed, and no approved medical device is implied.
03
Two sets of hands over a shared technical document on a pale desk
Who is accountable The site builds and tests the part. We carry the contract, the file and the export declaration.

07Execution layer · what to send

What to send, and what comes back.

Written assessmentInspection planTraceability scheme

A written assessment covering stackup and DFM, the class decision and its cost, the inspection and test plan, the traceability scheme, and the questions a reviewer would ask.

Q1
A blank unmarked form on a clipboard with abstract ruled lines and empty tick boxes
What do I send with the enquiry? Intended use and device class, the regulatory pathway, target IPC class, sterilisation method, traceability depth, annual volume and the change-notification window you require.
Q2
A technical scope document beside a board sample on a pale bench under even light
Will a supplier certificate satisfy my reviewer? No. ISO 13485 covers the quality system. Your registration, clearance or conformity route is a separate obligation.
Q3
An open container on a pale loading apron with unlabelled cartons on pallets
What are the commercial terms? Default FOB; FCA where the goods are stuffed inland; CFR or CIF only when we sell the freight. The ex-works rule is not quoted.

08Start

Send us your device spec, class and pathway.

Intended use, device class, regulatory pathway and traceability depth.

Recorded. An engineer will reply.

Default term is FOB, FCA for inland stuffing. The ex-works rule is not quoted. Written assessment from eric@dfshk.cn.

What comes back eric@dfshk.cn · +86 152 3512 7440