MEDICAL ELECTRONICS MANUFACTURE
Medical Electronics Manufacture for High-Reliability Medical Devices ISO 13485 Certified
We Offer Contract Medical Electronics Manufacturing Service to Medical Device Customers
Backed by ISO 13485 certification, we build robust quality systems into every stage of medical electronics manufacture, ensuring full traceability, repeatability, and audit-ready documentation. Our team’s deep knowledge of regulatory processes (including MDR and FDA expectations), process validation, and risk management means your devices are produced to the highest standard ready for clinical use and critical environments.
From NPI and DFM to cleanroom assembly, testing, and lifecycle support, we deliver medical electronics manufacturing that reduces risk, accelerates time-to-market, and safeguards patient outcomes.
Medical PCB Assembly for Regulated Medical Devices
Cogent Technology delivers end-to-end Medical PCB Assembly for medical device manufacturers from prototypes to scaled production built around compliance, reliability, and swift time-to-market. Our experienced team supports everything from straightforward layouts to highly complex boards, with robust documentation and traceability throughout.
Our Medical PCB Assembly capabilities include:
Surface-mount assembly (SMT): High-accuracy placement for fine-pitch, BGA, uBGA, and mixed-technology builds tailored to medical device requirements.
Conventional (through-hole) PCB assembly: Reliable hand and wave processes for components and connectors used in clinical environments.
Sub-assemblies: Complete board-level and electro-mechanical sub-assemblies ready for integration into your medical device.
Quality control for medical builds: Controlled processes, recorded work instructions, and device history records to support audits and compliance.
Full inspection and test: AOI, X-ray (where applicable), in-circuit and functional testing to verify performance and ensure field reliability.
Partner with Cogent Technology for Medical PCB Assembly that reduces production risk and safeguards patient outcomes speak to our team about your build requirements.
Medical Box Build Assembly for Regulated Medical Devices
Cogent Technology delivers turnkey medical box build assembly from PCB and cable sub-assemblies to fully integrated, electromechanical enclosures ready for final device integration. Built on ISO 13485 quality systems, our process emphasises compliance, repeatability, and complete traceability to support audits and patient-critical performance.
Our medical box build assembly capabilities include:
Requirements & documentation review: BOMs, drawings, work instructions, and build records aligned to medical device documentation.
Electromechanical integration: PCB installation, cable harnessing, switches/HMIs, power modules, thermal management, and enclosure sealing/fastening.
Testing & programming to spec: Firmware loading, configuration control, and functional testing verified against your test procedures.
Full traceability: Component lot control, serialisation, and device history records to support regulatory compliance.
Branding, labelling & packaging: Product branding and compliant labelling with packaging configured for global distribution
Medical Device Consultancy
Whether your business is an established medical device manufacturer or an emerging med-tech company, the experience the Cogent team can bring to bear in supporting your device through approvals or ensuring your quality management system will withstand the scrutiny of an audit can be invaluable.
Our Business Development Manager sits on the BSI ISO13485 steering committee, so we are always ahead of the game.
Medical Electronics Manufacturing
What our clients say
Contact Us
Langer Road
Felixstowe
Suffolk, IP11 2BF
United Kingdom
