Medical Electronics Manufacturing for the MedTech Sector

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Market segment · MedTech

Electronics for
life-critical care

NOTE in the UK builds PCB assemblies, box builds and complete systems for medical device manufacturers, with ISO 13485 certification at Basildon and Wolverhampton and assemblies built to IPC Class 3, from engineering prototype to volume production.

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Watch the line in action

ISO 13485 · IPC-A-610 Class 3 · ISO 9001

Ultrasound scanner with monitor and control panel in a hospital room

6

UK manufacturing
sites

600+

UK
colleagues

£44.2bn

UK medtech
turnover

2027

EU MDR deadline for
class III devices

Sources: Office for Life Sciences, Bioscience and health technology sector statistics 2024 to 2025; EU Regulation 2023/607 on the MDR transitional provisions.

What we build

Precision electronics for
medical devices

NOTE in the UK manufactures electronics for medical device OEMs - from diagnostic equipment and patient monitoring systems to surgical devices, implantable electronics and life-support systems. Our Basildon and Wolverhampton (Kasdon Electronics) sites are certified to ISO 13485, and we build to IPC Class 3, the highest workmanship standard for electronic assemblies. Every programme runs under validated processes, with batch traceability records and documented change control. From DFM and prototyping through to volume PCBA, box build and long-term after-sales support, the same engineering and quality team stays with your programme for its full life, which in MedTech often means many years.

Diagnostic
equipment

Control and processing electronics for diagnostic systems, built and tested to a customer-approved specification.

Patient
monitoring

Monitoring boards and assemblies where reliability and traceability matter on every build.

Surgical
devices

Electronics for surgical instruments and systems, with AOI and X-ray inspection as standard.

Implantable
electronics

Controller assemblies built under validated processes, with batch traceability records.

Life-support
systems

Electronics for life-critical equipment, where there is no room for compromise on workmanship.

Cable
assembly

Cable assemblies built to IPC Class 3 alongside your PCBAs and box builds.

Box build and
system integration

Complete devices assembled, integrated and functionally tested before despatch.

Inspection
and test

AOI and X-ray inspection as standard, with functional test to your approved specification.

Why OEMs come to us

What brings MedTech
OEMs to NOTE

01

Traceability you
can submit

Batch records, first article inspection reports and archived test results come as standard, ready for regulatory submissions and audits.

02

Ready for tighter
regulation

MDR transition deadlines are approaching, and new UK post-market surveillance rules took effect in June 2025. Our documentation supports both.

03

One team from
NPI to volume

The same engineering and quality team runs your programme from DFM review and first article approval into volume, so nothing is lost at ramp.

04

Support for the
full device life

Medical programmes often run for many years. We manage obsolescence, validated engineering changes, repair and test.

How we manufacture

How we build
medical electronics

ISO 13485 at Basildon and Wolverhampton (Kasdon Electronics) and ISO 9001 across all six UK sites (Windsor, Haddenham, Basildon, Wolverhampton, Hook and Poynton), with assemblies built to IPC-A-610 Class 3.

Talk to our team

01

Validated
processes

Validated manufacturing processes with documented change control, so every build matches the one you approved.

02

IPC Class 3
assembly and test

PCBA, box build and cable assembly to IPC Class 3, with AOI and X-ray as standard and functional test to your approved specification.

03

DFM and
DFT review

Our engineers review every design before first build and plan the test strategy at NPI, protecting yield and shortening time to approval.

04

Batch
traceability

Batch traceability records and archived test results, ready for audit and regulatory submissions.

deep blue background right

Inside NOTE: MedTech electronics · 1:39

See it on the line

From the line to
patient care

A short look at medical electronics at NOTE, from the devices our customers make to the teams who build them.

  • Where it ends up: diagnostics, patient monitoring and surgery
  • Precision assembly by our teams
  • Inspection and test at every stage
  • Flexibility, quality and reliability, to ISO 13485
Talk to our team about your build

What Our Customers Say

  • Diagnostic Equipment

    “NOTE‘s ISO 13485 processes gave us complete confidence from day one. Full batch traceability, first article approval, and a DFM review that caught two potential yield issues before first build. They shortened our regulatory submission timeline by six weeks.”
    Director of Operations,
    Diagnostic Equipment OEM

  • Patient Monitoring Systems

    “We’ve worked with NOTE in the UK across three product generations. The same programme manager, the same quality team, the same traceability standard, every time.
    That continuity is what long-lifecycle medical programmes demand.”
    Head of Supply Chain,
    Patient Monitoring OEM

  • Surgical Instruments

    “NOTE‘s IPC Class 3 discipline and AOI-on-every-build approach means we receive assemblies we can trust.
    Zero concessions on workmanship, and a team that flags potential issues before they reach us.”
    VP Operations,
    Surgical Device Manufacturer

One partner, end to end

Where we support your
MedTech programme

DEVELOPMENTPRODUCTIONAFTER-SALES INTRODUCTIONGROWTHMATURITYDECLINEMAINTENANCE

01 Development

Design support, DFM reviews and component selection, so your board is ready to build from day one.

Explore Development →

Next steps

Starting a project
with NOTE

1

Send us your
brief

Share your drawings, BOM or just the problem you are trying to solve.

2

Review
and quote

Our engineers check your design for manufacturability and come back with a quote.

3

First
prototypes

We build your first prototypes so you can test before committing to volume.

Request a quote

Frequently asked questions
MedTech manufacturing

A: NOTE in the UK holds ISO 13485 certification for medical device manufacturing at Basildon and Wolverhampton (Kasdon Electronics), and manufactures to IPC Class 3 workmanship standards. ISO 9001 is held at all six UK sites: Windsor, Haddenham, Basildon, Wolverhampton, Hook and Poynton. Manufacturing processes are validated to ISO 13485 requirements at both sites, with documented first article inspection, test result archiving and full change control documentation to support regulatory submissions and post-market surveillance requirements.

A: ISO 13485 is the international quality management standard for the design and manufacture of medical devices. It extends ISO 9001 with additional requirements specific to medical device regulation, including design control, risk management, process validation, traceability, post-market surveillance support and documented change control. It is required by the UK MDR 2002 and aligned to EU MDR requirements.

A: NOTE in the UK manufactures electronics for diagnostic equipment, patient monitoring systems, surgical devices, implantable electronics and life-support systems. The common thread is demanding quality, traceability and regulatory compliance requirements, which NOTE’s ISO 13485-certified sites at Basildon and Wolverhampton are built to meet.

A: Every MedTech build at NOTE in the UK runs under validated processes, with batch traceability records, first article inspection reports and archived test results as standard. Changes go through documented change control, so your records are ready for regulatory submissions and audits.

A: Yes, with the manufacturing evidence you need. Batch records, first article inspection reports, archived test results and validated change control support your technical file and post-market surveillance. Regulatory conformity and CE or UKCA marking remain with you as the device manufacturer.

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