Medical Device Hardware Development — FDA, IEC 62304 & ISO 13485 Compliant
Rapid Circuitry designs and develops Class I, II and III medical device electronics and firmware — from concept through FDA 510(k) and CE-marking support. We design under ISO 13485 quality controls, build software to IEC 62304, engineer electrical and patient safety to IEC 60601-1, and integrate ISO 14971 risk management across the project. Our medical work spans FDA-cleared wearables, NICU life-support, and closed-loop therapeutic systems.
What we develop
Remote Patient Monitoring & Wearables
ECG, PPG, SpO₂, temperature and multi-parameter wearables with long battery life, BLE/cellular connectivity, and edge signal processing for continuous monitoring.
Diagnostic & Point-of-Care Devices
Analyzers, assay readers and bedside diagnostics with precision analog front-ends, fluidics control, and secure data handling for clinical environments.
Therapeutic & Life-Support Systems
Closed-loop therapeutic devices, infusion and oxygen-delivery control, and stimulation systems engineered for IEC 60601-1 electrical and patient safety.
Neonatal & Critical-Care Devices
NICU-grade instrumentation with redundant safety, alarm management (IEC 60601-1-8) and tight measurement accuracy for the most vulnerable patients.
Standards & regulatory compliance we design to
Compliance is engineered in from the first schematic, not retrofitted before testing. We design to the standards that govern medical electronics and produce the evidence your quality and regulatory team needs.
FDA 510(k) / PMA
US market clearance
Design controls and documentation aligned to the regulatory pathway, with engineering support for predicate comparison and submission packages.
ISO 13485
Medical QMS
We design under a quality-management framework with full traceability — we can also operate under your existing ISO 13485 QMS.
IEC 62304
Medical device software
Software lifecycle with safety classification (Class A/B/C), architecture, unit/integration verification, and SOUP management.
IEC 60601-1
Electrical & patient safety
Means of protection (MOOP/MOPP), creepage/clearance, leakage current and isolation engineered in from schematic stage, with pre-compliance testing.
ISO 14971
Risk management
Risk analysis, FMEA and risk controls integrated across the hardware and firmware design, not bolted on at the end.
IEC 62366-1
Usability engineering
Human-factors and use-error analysis to support a safe user interface and the usability file regulators expect.
Our medical device development process
- 1
Concept & feasibility — clinical requirements translated into a testable hardware/firmware architecture and intended-use definition.
- 2
Risk analysis (ISO 14971) — hazard analysis and risk controls established before design, feeding requirements.
- 3
Hardware & firmware design — schematic, PCB, and IEC 62304-aligned firmware with design controls and traceability.
- 4
Verification & pre-compliance — IEC 60601-1 / 60601-1-2 (EMC) pre-compliance and design verification against requirements.
- 5
Design History File — complete DHF, V&V records, and risk file ready for your regulatory or quality team.
- 6
Submission & transfer support — engineering support through 510(k)/CE technical documentation and design transfer to manufacturing.
Medical device case studies
FDA-Cleared Remote Patient Monitoring Wearable
99.2% arrhythmia detection · 14-day battery
Nitric Oxide Therapy System for NICU
Neonatal life-support instrumentation
AI-Driven Oxygen Therapy Controller
Closed-loop SpO₂-targeted oxygen delivery
Smart Urinometer for Critical Care
Automated urine-output monitoring
Sensor-Driven Robotic Prosthetic Arm
Myoelectric control & embedded actuation
Why Rapid Circuitry for medical devices
Documentation that survives audit
Controlled design inputs/outputs, V&V records, and a complete Design History File — not reverse-engineered after the fact.
Risk-first engineering
ISO 14971 hazard analysis drives requirements, so safety is designed in rather than tested in.
Proven clinical track record
FDA-cleared, NICU, and closed-loop therapeutic devices already in the field.
Frequently asked questions
Do you develop FDA 510(k) and CE-marked medical devices?
Yes. We design medical device electronics and firmware under design controls and provide the engineering documentation — design inputs/outputs, verification and validation records, and the Design History File — that your regulatory team needs for an FDA 510(k) submission or CE technical file. We are an engineering partner, not a regulatory consultancy, so we work alongside your quality/regulatory lead or recommended consultants.
Can you work under our existing ISO 13485 quality system?
Yes. We can operate under your ISO 13485 QMS and procedures, or apply our own controlled design process with full traceability that your QMS can absorb. Either way you receive controlled documentation suitable for audit.
What is IEC 62304 and do you follow it?
IEC 62304 is the standard for medical device software lifecycle processes. We classify software safety (Class A, B or C), define a software architecture, maintain requirements-to-test traceability, manage SOUP (software of unknown provenance), and produce verification evidence appropriate to the class.
Do you handle IEC 60601-1 electrical safety and EMC?
We engineer IEC 60601-1 requirements — means of patient/operator protection, isolation, creepage and clearance, and leakage current — from the schematic stage, and run IEC 60601-1-2 EMC pre-compliance so the device is ready for an accredited test lab with minimal surprises.
Which classes of medical device do you work on?
Class I, II and III device electronics, including life-support and neonatal/critical-care systems. Higher-risk classes simply carry more rigorous risk management, verification, and documentation, which we plan for from the start.
How do you manage risk and traceability?
We integrate ISO 14971 risk management across the project — hazard analysis, FMEA, and risk controls that flow into requirements and verification — rather than documenting risk after the design is frozen. Every requirement traces to a design output and a verification result.
Can you take a device from concept all the way to manufacturing?
Yes. We cover concept and feasibility, hardware and firmware design, verification and pre-compliance, the Design History File, and design transfer to your contract manufacturer, with manufacturing and production support available.
Do you have real medical device experience?
Yes — our case studies include an FDA-cleared remote patient monitoring wearable, a NICU nitric-oxide therapy system, an AI-driven oxygen therapy controller, a critical-care smart urinometer, and a sensor-driven robotic prosthetic arm.
Building a medical device?
Talk to our engineering team about your device, target classification, and regulatory pathway. We'll map the hardware, firmware, and compliance plan to get you to clearance.
Discuss your medical device