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On this page (10 sections)
Traceability and documentation
Every build is recorded: component lots, process steps, inspection and test results. Records are available to support your design history, device master record and audits.
Traceability allows any issue to be investigated quickly and the scope of any corrective action to be defined precisely, protecting patients and your organisation.
Testing that protects patients
We build custom functional test fixtures so each unit is verified against specification before shipping. Burn-in and stress screening can be added for higher-risk products.
Test limits and procedures are agreed with your engineering and quality teams, and any changes are controlled and documented.
From prototype to production
Medical products often move through several prototype rounds and clinical or field trials before launch. We support small batches during development and scale to regular production once your device is approved.
Moving between stages with the same partner keeps knowledge in one place and reduces the risk of changes being introduced unintentionally.
Designing for safety
Medical electronics often need isolation between mains and patient-connected circuits, low leakage currents and fail-safe behaviour. Our engineers design with these requirements in mind and work with your regulatory team to align with the standards that apply to your device.
Safety considerations are documented during design so your regulatory team has the information needed for risk management files.
Change control
Changes to a medical device must be controlled. Every change to components, processes or documentation is recorded and approved before it is used in production, and builds are traceable to the revision they were made to.
Customers are informed of proposed changes and approve them before implementation, maintaining confidence in the product.
Supporting start-ups and established companies
Medical start-ups need help moving from prototype to a manufacturable design. Established companies need a dependable supplier for existing products. We support both, from early prototypes to regular production.
Whatever your stage, we tailor documentation, testing and communication to your requirements.
Typical device architectures
Many medical and laboratory devices share a common structure: sensors or electrodes, an analog front end, a microcontroller, a display and user controls, data storage or communication, and an isolated power supply. We design and manufacture each of these building blocks and integrate them into a complete product.
Building on proven blocks reduces development risk and helps devices reach evaluation and production sooner.
Cleanliness and handling
Electronics for medical devices must be clean and free from flux residues that could affect reliability. Boards are cleaned where required, handled with ESD precautions and packed to protect them from contamination during transport.
Cleanliness requirements are agreed in advance and verified during inspection.
Reliability testing
For devices where failure is unacceptable, we can add extended functional testing, burn-in at elevated temperature and sample-based environmental testing. Results are recorded and shared so you can include them in your technical documentation.
Reliability data supports your risk analysis and gives confidence in long-term performance.
Working with your quality system
Medical device companies operate under their own quality management systems. We align with your supplier requirements, provide the records you need and support supplier audits.
We adapt our records and processes to fit your supplier requirements without unnecessary complexity.