Industries · Medical devices
Board assembly for patient monitors, infusion and syringe pumps, ventilators, imaging subsystems, IVD analysers and wearables. Our ISO 13485:2016 certificate scope reads Production of PCBA. This is a quality-management-system certificate — it is not an FDA clearance and it is not an EU MDR certificate. The obligations under FDA 21 CFR 820 and EU MDR 2017/745 sit with the legal device manufacturer, which is you; what we deliver is a traceable board plus the lot-level traceability and IQ/OQ/PQ validation documentation your own submission depends on. Sterilisation tolerance is quoted against your method: autoclave at 134 °C / 2 atm / 18 min, gamma to 50 kGy cumulative, or EtO validated per ISO 11135. Assembly lead time ex-components.
Read the certificate correctly
Quality and regulatory teams arrive with a supplier questionnaire already written. The first section is always the same, and it is the one where vague answers end the conversation.
ISO 13485:2016 is a quality-management-system standard for organisations in the medical device supply chain. Our certificate, first issued in 2021, covers the production of PCBA. It says our quality system is audited against that standard; it does not approve any device and it does not authorise anyone to place a device on any market.
This is a quality-management-system certificate — it is not an FDA clearance and it is not an EU MDR certificate. We do not hold an FDA clearance, and no ISO 13485 certificate substitutes for one. Under FDA 21 CFR 820 and EU MDR 2017/745 the obligations belong to the legal manufacturer of the device: your technical file, your conformity assessment, your notified body relationship.
What we owe you is evidence. Every production lot is traceable to the component lots consumed and the process records generated, so a field problem can be narrowed to a shipment, a lot and a date code instead of recalling a year of production. Validation documentation is generated as a package you can attach to your own records, not as a marketing claim.
If your quality agreement requires the right to audit our site, that clause is signed before the first production order, and a scheduled visit can walk the line, the inspection stations and the retained records for your own part numbers.
Supplier approval
Medical supplier questionnaires converge on six subjects. Each row below states what is normally required and what we can actually evidence — including the two entries that are risk-derived rather than fixed by any standard.
| Requirement | What the buyer specifies | VOLTCIRCUIT evidence |
|---|---|---|
| Quality systemScope must name assembly | ISO 13485:2016 certification whose scope explicitly covers board assembly, not distribution or design | ISO 13485:2016 certified since 2021, scope Production of PCBA. A quality-management-system certificate — not an FDA clearance and not an EU MDR certificate. |
| Traceability and records | Board-level records traceable to component lot and date code, retained for the life of the device plus ten years | Lot-level traceability on every shipment, linking bare-board lot, component lots and process data to the carton lot identification. Records are retained under the terms agreed in the quality agreement. |
| Validation documentation | IQ/OQ/PQ process validation evidence that the customer can reference in its own technical file | Installation, operational and performance qualification documents generated for the process steps in scope, plus first-article inspection reports carrying SPI and AOI data and the visual acceptance criteria applied. |
| Change control | Notification before any change to process, material or supplier, because a change can invalidate the customer's own validation | Written notification before a process or material change is implemented; every component substitution requires a datasheet parameter comparison and the customer's written approval. We never substitute automatically. |
| Materials and biocompatibility | Material declarations and, where a coating or potting compound contacts the patient, biocompatibility evidence | RoHS 3 (EU) 2015/863 and REACH SVHC declarations available on request, plus a CMRT for 3TG sourcing. ISO 10993 biocompatibility applies where conformal coating or potting touches the patient — it is not a blanket requirement on every board. |
| Sterilisation and cleanliness | Assemblies that survive the sterilisation method and a cleanliness level justified by risk | Component and coating selection screened against the sterilisation method: autoclave at 134 °C / 2 atm / 18 min, gamma to 50 kGy cumulative, or EtO validated per ISO 11135. Ionic contamination measured by ROSE testing to IPC-TM-650 against Class 2 ≤1.56 or Class 3 ≤0.78 µg NaCl eq/cm². The cleanroom class itself is a risk-assessment output under ISO 13485 clause 6.4 — no standard prescribes a fixed number, and we will not quote one as if it did. |
Why traceability depth is priced in
Traceability is not a document exercise. It decides whether a problem is contained to one shipment or becomes a market-wide action, and that difference is measured in millions.
US device recalls reached 1,059 events in 2024, the highest in four years, with Class I actions at their highest share in fifteen years and 440.4 million units affected — up 55.4% from 283.4 million. When the affected population is measured in hundreds of millions, the ability to prove that your boards were not in the implicated lots is worth more than the boards cost.
Published recall cost ranges run from USD 500,000 to more than USD 50 million in direct product cost per action, with legal and liability exposure from USD 1 million to more than USD 100 million. These are industry illustrations rather than our figures, and they are the reason traceability data is requested before price is discussed.
A conformal coating swap, a different laminate, a new soldering profile or a new component source can each invalidate the customer's validated state, which means the change has to be notified, assessed and documented before it happens. Suppliers who change first and report afterwards create a regulatory problem for the device manufacturer, not just a quality one.
Autoclave cycling at 134 °C for 18 minutes, gamma exposure to 50 kGy cumulative, or EtO validated per ISO 11135 each impose different limits on what can be fitted. Electrolytic capacitors, some plastics and many adhesives have to be screened against the intended method at sourcing stage, because discovering the incompatibility after the board is designed forces a redesign.
A supplier questionnaire that asks how far back a finished board can be traced is asking whether a suspect component lot can be identified without scrapping unrelated production. Recording the bare-board lot, the component lots and the process data per shipment is what makes a narrow, defensible recall scope possible.
ISO 13485 clause 6.4 requires documented, risk-justified control of the work environment; it does not name a numeric cleanroom class. We operate an ISO Class 8 clean area for coating and sensitive assembly, and we state the level as our own controlled environment rather than as a figure some standard mandates.
Record
A US Class II device company needed an assembly partner whose quality system and record-keeping could sit inside its own regulatory framework. The requirement was explicit: an ISO 13485 system, traceability down to component lot, and a validation documentation package its own notified body would accept. We built the lot-level traceability scheme for an eight-layer monitor mainboard, produced the IQ/OQ/PQ documentation set, and agreed the change-notification and re-validation triggers in writing before the first production order.
Deliverables
Each shipment carries a lot identification that opens the record for that run: the bare-board lot from the partner fab, the component lots and date codes consumed, the stencil and reflow profile used, and the SPI, AOI and X-ray results captured for that build. This is what allows a suspect batch to be isolated without touching unrelated production.
Scope: board lot → component lots → process data
Installation, operational and performance qualification records for the process steps in scope, supported by first-article inspection reports that carry SPI and AOI data plus the visual acceptance criteria applied. The package is written so it can be referenced directly in your own technical file rather than summarised by us.
Contents: IQ/OQ/PQ + FAI report with SPI and AOI data
A written list of what counts as a change on your part number — process step, material, coating chemistry, component source — and what each one triggers. Component substitutions require a parameter comparison and your written approval before implementation; parts already on your approved vendor list are preferred.
Rule: no automatic substitution, triggers agreed in writing
Next step
Quality and regulatory teams usually know exactly which clauses need an answer. Send the questionnaire with the BOM and the assembly drawings, and we will answer it against what we hold — including the entries where the certificate scope, the cleanroom class or a declaration is not what the form assumes. Assembly lead time ex-components; long-lead semiconductors can add 12–26 weeks.
Reply within one business day
Medical builds are quoted once the validation documentation is agreed. Quantities start at 50 pcs plus 30 spares for 0603–2225, SOT, SOD and MELF packages, and 100 pcs plus 50 spares for others.
Related reading: quality and inspection scope, all six industry pages, and automotive and EV.