MedTech devices

Medical

Medical electronics carry a documentation burden equal to the engineering one. We build the design history alongside the device, because a design that cannot be evidenced cannot be approved.

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The operating constraint

What makes this sector hard

Every one of these has cost somebody a programme. They are the questions we ask first, before any architecture is proposed.

Design history and risk files that must be built during development, not after
Patient-contact materials, biocompatibility and cleaning-cycle survival
Electrical safety and EMC to IEC 60601 with no room for interpretation
Measurement accuracy that has to hold across the specified operating range
Software of unknown provenance excluded from anything on the safety path

What you get

A submission-ready design history built during development, not reconstructed
Pre-compliance findings resolved before the formal EMC booking
Measurement accuracy demonstrated across the full specified range

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Capabilities

What we build for medical

Device ElectronicsLow-noise analogue front ends, isolation, and precision measurement chains

Connected DiagnosticsBLE and cellular links with secure pairing and integrity-checked payloads

Safety & EMC ComplianceIEC 60601-aligned design, pre-compliance testing, and certification support

Design History & RiskRequirements traceability, risk analysis, and verification records as you go

Controlled ManufacturingDocumented process, traceable components, and inspection records per unit

How we work here

The approach, in practice

Medical programmes rarely fail on the electronics. They fail on evidence — a verification result nobody recorded, a component change nobody traced, a risk control with no test behind it. We treat the design history file as a deliverable of the engineering work rather than a document written at the end from memory.

Key technologies