Medical devices: electronics designed for compliance
Designing a medical device is not adapting an industrial board after the fact: it means building patient safety, software traceability and risk management into every design decision. We designed a custom medical-class lighting product, engineered for certification from the schematic. Our medical projects run under NDA: we describe problem classes, never our clients’ products.
Compliance as a design constraint
The medical framework (IEC 60601-1 for electrical safety, IEC 62304 for the software lifecycle, ISO 14971 for risk management, EU MDR 2017/745 for market access) cannot be retrofitted at the end of a project. On our medical projects, every architecture, isolation and component choice is documented with the technical file in mind: that is what makes certification predictable instead of a gamble.
Medical-class work
We designed a custom medical-class lighting product, engineered for certification from day one. We also design biometric sensors for medical IoT, where measurement accuracy meets low-power constraints. And the house rule fully applies to medical: 100% success rate on CE/FCC certifications.
The means engaged
Climate-chamber qualification from -40 to +85 °C, pre-compliance EMC in our chamber (hospital environments are demanding on immunity), signal-integrity validation on the Tektronix TekExpress bench for fast links, and Nordic PPK2 power profiling for battery devices. The traceability of these measurements feeds the MDR technical file directly.
30 minutes with an engineer to frame your project: target class, architecture, IEC 60601 / IEC 62304 / MDR regulatory path.
FAQ
- Which medical device classes do you cover?
- Our expertise covers the electronics of class I, IIa, IIb and III devices under EU MDR 2017/745; the exact classification depends on the intended use claimed for the final product, which remains the manufacturer’s responsibility.
- Do you handle medical embedded software?
- Yes, with a software lifecycle aligned with IEC 62304: traced requirements, documented reviews, tests linked to the risks identified per ISO 14971. Medical embedded software is designed together with its file, not before it.
- Why do you show no client product?
- Because our medical projects are under NDA. The work described here corresponds to project classes actually delivered, phrased to be verifiable without identifying our clients.