UK PCB manufacture, assembly and electronic design for safety-critical medical electronics, from a UK sovereign manufacturer trading since 1956 and ISO 13485:2016 certified for contract assembly and population of PCBs and electronic assemblies for the medical device industry.
Key facts: ISO 13485:2016 certified (MD 825732) · UK manufacturer since 1956 · PCB fabrication, assembly and electronic design in-house · Selected PCB fabrication from 24 hours.
Established in 1956, Newbury Electronics provides PCB fabrication, PCB assembly and electronic design support for companies developing medical electronics. Design, fabrication, assembly, inspection and test are coordinated in-house at Newbury's UK sovereign facility, with electronic development available through Newbury Innovation.
Newbury's capabilities cover prototype, low-volume and higher-volume PCB requirements, alongside automated assembly, inspection, functional testing, conformal coating and other supporting processes. Keeping these stages under one roof supports shorter development cycles, closer control of design IP and a single UK manufacturing route for development and production requirements, with the appropriate process, documentation and quality controls agreed for the project.
For medical-device electronics assembly, Newbury Electronics holds ISO 13485:2016 certification, certificate MD 825732. The certificate scope is the contract assembly and population of printed circuit boards and electronic assemblies for the medical device industry. This certification applies to Newbury Electronics' certified quality-management scope; it does not certify a customer's finished medical device.
Medical device electronics buyers are increasingly expected to demonstrate risk management aligned to ISO 14971, safety considerations informed by IEC 60601 and, where applicable, software lifecycle practices consistent with IEC 62304, alongside the transition toward UK MDR/UKCA and EU MDR requirements. These are standards the sector is assessed against, not certifications held by Newbury Electronics; Newbury's ISO 13485 quality-management system and documented traceability are intended to support the manufacturing evidence an OEM's own regulatory submission may require.
For medical electronics projects, manufacturing decisions can involve board construction, assembly technology, inspection, testing, documentation and the quality system under which the work is performed. Newbury's capability spans multilayer PCB manufacture, SMT and through-hole assembly, AOI, X-ray, functional test, conformal coating and other supporting services. The manufacturing route can therefore be matched to the board design, production stage and agreed project requirements.
Medical electronics projects can require controlled assembly, repeatable inspection, traceable manufacturing information and engineering input as designs move from prototype into production. Newbury's capabilities cover the PCB and electronics manufacturing activities needed across those stages.
Newbury manufactures bare PCBs from prototype and small-batch requirements through medium and higher-volume production. Capabilities include multilayer boards, a range of materials and finishes, and fast-turnaround options through its PCB fabrication services.
SMT and through-hole assembly are supported with automated placement, reflow, selective soldering, inspection and testing. Fine-pitch and BGA placement, AOI and in-house X-ray are among the assembly capabilities.
Newbury Innovation supports electronic product development for medical and wearable applications, including circuit design, firmware and software development, PCB layout, DFM optimisation and project requirements capture.
Newbury Electronics is certified to ISO 13485:2016 for the contract assembly and population of PCBs and electronic assemblies for the medical device industry. Other quality and information-security credentials can be reviewed on the approvals page.
Medical electronics programmes can require more than PCB fabrication alone. Board construction, component placement, inspection, testing, documentation and design-for-manufacture all need to work together as a product moves from prototype into repeatable production.
Newbury provides a broad PCB manufacturing and assembly capability, allowing these requirements to be considered together. Selected PCB fabrication services can be available from 24 hours, subject to board type and requirements, while the assembly facility operates 10 SMT machines with total placement capacity of circa 250,000 components per hour.
Newbury's medical-sector content and electronic design experience support a range of medical and healthcare electronics applications, particularly where compact electronics, monitoring, instrumentation or connected hardware are required.
Newbury Innovation also has a medical-device case study covering wearable health monitoring and product development for medical technology. Read the medical devices case study.
Medical electronics development benefits from clear technical requirements, controlled iteration and a manufacturing route that can be reviewed early. Newbury can support the relevant stage of the journey through manufacturing and, where required, Newbury Innovation's electronic design services.
For regulated product development, the manufacturing handover is strongest when the design intent, inspection requirements and acceptance criteria are clear before production begins. Newbury Innovation follows a requirements-capture approach covering circuit analysis, system integration, test and acceptance criteria, and electrical and mechanical constraints.
Capture the product's technical requirements, interfaces, test and acceptance criteria, and relevant electrical and mechanical constraints.
Develop or refine the electronic hardware, firmware, software and PCB layout, with DFM considerations built into the development process.
Manufacture prototype PCBs and assemblies for engineering evaluation, iteration and early verification against the agreed requirements.
Refine the design and manufacturing process before production, including inspection, testing and documentation requirements appropriate to the project.
Move into repeatable PCB fabrication and assembly within the applicable manufacturing and quality processes, with production information and traceability managed to the agreed requirements.
Newbury Electronics holds ISO 13485:2016 certification, certificate MD 825732. The certificate scope is the contract assembly and population of printed circuit boards and electronic assemblies for the medical device industry.
For procurement and quality review, the current certificate and the wider approvals list should be used as the source of record. In practice, the applicable drawings, specifications, standards, inspection requirements and acceptance criteria still need to be defined for each project. ISO 13485 certification describes Newbury Electronics' certified quality-management scope; it is not a certification of a customer's finished medical device.
The following statements distinguish Newbury Electronics' quality-management certifications from manufacturing capabilities and project-level requirements.
| Credential / control | Certificate no. | Scope | Expiry |
|---|---|---|---|
| ISO 13485:2016 | MD 825732 | Contract assembly and population of printed circuit boards and electronic assemblies for the medical device industry. | 17/02/2029 |
| ISO 9001:2015 | FM 40205 | PCB assembly, electronic assemblies, laser-cut stencils. | 19/12/2026 |
| AS9100D / EN9100:2018 | FM 833030 (fabrication); FS 719374 (assembly) | PCB fabrication and assembly for aerospace, defence and other sectors; not presented here as a medical-device certification. | 22/04/2029; 18/01/2027 |
| ISO/IEC 27001:2022 | 493672025 | Information security management system, covering the handling of customer design data and IP. | 15/09/2029 |
| ISO 14001:2015 / ISO 45001:2018 | 439832024 | Environmental and occupational health and safety management. | 20/02/2028 |
| Cyber Essentials Plus | e8d53e44-… | Whole-organisation cyber security, independently audited. | 23/02/2027 |
| Cyber Essentials | 0a16944a-… | Whole-organisation cyber security, base tier. | 19/02/2027 |
| JOSCAR | 10023472 | Aerospace, defence, security and space supplier register. | — |
| Underwriters Laboratories | E132578 | PCB material and component safety. | Ongoing |
| IPC specialist certification | — | Individually certified staff, including IPC-A-610 and IPC-7711/7721; project acceptance criteria remain subject to the applicable contract and documentation. | — |
| Inspection and test | — | Manufacturing capabilities include AOI, in-house X-ray, electrical/functional test, dimensional inspection and other process controls depending on project requirements. | — |
Newbury Electronics is a UK PCB manufacturer providing PCB fabrication and PCB assembly services for medical electronics. Its capabilities cover prototype, small-batch, medium and higher-volume PCB requirements, with assembly and inspection services available for electronic products.
Yes. Newbury Electronics manufactures bare PCBs and provides PCB assembly for medical electronics. Medical applications listed by Newbury include diagnostic and monitoring equipment, laboratory instrumentation, patient-worn and portable medical devices, medical IoT hardware and embedded control systems.
Yes. Newbury Electronics holds ISO 13485:2016 certificate MD 825732. The BSI certificate scope is the contract assembly and population of printed circuit boards and electronic assemblies for the medical device industry.
PCB assembly capabilities include SMT and through-hole assembly, fine-pitch and BGA placement, AOI, in-house X-ray inspection, convection and vapour-phase reflow, selective soldering, CNC depaneling, conformal coating and functional testing.
Yes. Newbury provides PCB manufacturing and assembly services covering prototype and low-volume requirements as well as medium and higher-volume production. The appropriate manufacturing route depends on the board, assembly and project requirements.
Newbury offers selected PCB fabrication services with turnaround from 24 hours, subject to board type and requirements. PCB Train Express currently lists around 24 hours for 2-layer PCBs and around 48 hours for 4-layer PCBs.
Capabilities include automated optical inspection, in-house X-ray inspection, electrical testing and functional testing. Inspection and acceptance criteria should be defined by the applicable drawings, specifications, standards and procurement documentation for the project.
Yes. Newbury Innovation has electronic development experience across medical and wearable applications. Services include requirements capture, circuit and hardware design, firmware and software development, PCB layout, DFM optimisation and system integration considerations.
Newbury's medical-sector content lists diagnostic and monitoring equipment, laboratory instrumentation, patient-worn and portable medical devices, medical IoT hardware and embedded control systems. Its medical-device case study also covers wearable health monitoring.
For PCB and assembly quotations, Newbury's PCB assembly information identifies BOM and Gerber data as core information. Additional drawings, specifications, quantities, component information, test requirements and other project documentation may be required depending on the build.
Yes. Newbury Electronics provides PCB fabrication and assembly, while Newbury Innovation provides electronic design and development. The wider Newbury Group positions these capabilities as a route from design through manufacture, with the exact services combined according to project requirements.
Newbury Electronics holds ISO/IEC 27001:2022 certification for information security management and Cyber Essentials Plus, an independently audited whole-organisation cyber security standard. Keeping design, fabrication and assembly in-house at a single UK site also limits the number of parties handling customer design data.
No. ISO 13485:2016 certifies Newbury Electronics' own quality-management system for contract assembly and population of PCBs and electronic assemblies; it does not certify a customer's finished device. Requirements such as EU MDR, UK MDR/UKCA, ISO 14971, IEC 60601 and IEC 62304 apply to the OEM's device and remain the OEM's responsibility, though Newbury's documented traceability can support the manufacturing evidence a regulatory submission may need.
Whether you're a medical device OEM, diagnostics company, contract manufacturer or design house, Newbury Electronics can discuss the manufacturing and engineering requirements for your bare PCB, medical PCB assembly or electronic design project and identify the appropriate next step.
