Industries
Rapid Circuitry designs medical device electronics and firmware from concept through FDA 510(k), De Novo or PMA documentation, EU MDR technical files and CDSCO registration, working to ISO 13485 design controls (or inside your QMS), IEC 62304, IEC 60601-1 and ISO 14971. Our wearable ECG monitor's 510(k) package is submission-ready, not cleared. Rapid Circuitry is not ISO 13485 certified.
What we build
ECG, PPG, SpO₂, temperature and multi-parameter wearables with long battery life, BLE/cellular connectivity, and edge signal processing for continuous monitoring.
Analyzers, assay readers and bedside diagnostics with precision analog front-ends, fluidics control, and secure data handling for clinical environments.
Closed-loop therapeutic devices, infusion and oxygen-delivery control, and stimulation systems designed to IEC 60601-1 electrical and patient-safety requirements.
Neonatal and critical-care instrumentation with redundant safety, alarm systems designed to IEC 60601-1-8 and tight measurement accuracy for the most vulnerable patients.
Standards
Regulatory requirements are 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.
US market authorisation
Design controls and engineering documentation for the pathway your device needs: predicate comparison for a 510(k), risk and performance evidence for a De Novo request, and engineering input to a sponsor's PMA for Class III devices.
EU and India market access
Technical documentation for Regulation (EU) 2017/745 (Classes I, IIa, IIb, III) with your notified body, and device and design information for CDSCO registration under India's Medical Devices Rules, 2017 (Classes A–D).
Medical QMS
Design documentation structured to ISO 13485 design-and-development expectations, with full traceability, so your QMS can absorb it. We can also work inside your existing ISO 13485 procedures.
Medical device software
Software lifecycle with safety classification (Class A/B/C), architecture, unit/integration verification, and SOUP management.
Electrical & patient safety
Means of protection (MOOP/MOPP), creepage/clearance, leakage current and isolation engineered in from schematic stage, with pre-compliance testing before the accredited-lab campaign.
Risk management
Risk analysis, FMEA and risk controls integrated across the hardware and firmware design, not bolted on at the end.
Usability engineering
Human-factors and use-error analysis to support a safe user interface and the usability file regulators expect.
How we work
Clinical requirements translated into a testable hardware/firmware architecture and intended-use definition.
Hazard analysis and risk controls established before design, feeding requirements.
Schematic, PCB, and IEC 62304-aligned firmware with design controls and traceability.
IEC 60601-1 / 60601-1-2 (EMC) pre-compliance and design verification against requirements.
Complete DHF, V&V records, and risk file ready for your regulatory or quality team.
Engineering input to your 510(k), De Novo or PMA submission and EU MDR or CDSCO technical documentation, and design transfer to manufacturing.
Proof
Medical Wearable
US-based digital health startup
Smart Urinometer
Medical device manufacturer, India
Automated Nitric Oxide Therapy System
Medical equipment manufacturer, India
AI-Powered Oxygen Therapy
Medical equipment manufacturer, India
Smart IV Infusion Pump
Medical-device company, India
Oral Screening Camera Probe
Medical-device client, India
Neonatal Vitals Wearable
Medical-device client, India
FAQ
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 an EU MDR technical file. None of our case-study devices is FDA-cleared yet; the wearable ECG monitor's 510(k) package is submission-ready. We are an engineering partner, not a regulatory consultancy, so we work alongside your quality/regulatory lead or recommended consultants.
Yes. We can work under your ISO 13485 QMS and procedures, or follow a controlled design process whose documentation is structured to ISO 13485 and IEC 62304 expectations so your QMS can absorb it. Rapid Circuitry does not hold ISO 13485 certification; the QMS of record is yours.
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.
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.
Class I and II device electronics, and Class III subsystems under your QMS, including neonatal and critical-care therapy systems. In the US most Class II devices go through 510(k) (or De Novo when there is no predicate) and Class III devices through PMA; the EU MDR uses Classes I, IIa, IIb and III, and India's CDSCO uses Classes A–D. Higher-risk classes carry more rigorous risk management, verification and documentation, which we plan for from the start.
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.
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.
Yes — our case studies include a remote patient monitoring wearable ECG whose 510(k) documentation package is submission-ready (not cleared), a NICU nitric-oxide therapy system, an AI-driven oxygen therapy controller, and a critical-care smart urinometer.
Each project is quoted as a fixed-scope proposal: a statement of work with milestones, deliverables and pricing, sent within 3–5 business days of the discovery call. The price depends on the requirements, how mature the design is, technical complexity, the number of prototype iterations and the validation scope. Longer engagements can also run as a retainer or a hybrid of both. For budgeting before you contact us, our hardware development cost benchmarks and the PCB design, firmware and IoT cost guides give indicative ranges with their assumptions stated. They are planning ranges, not quotes.
It depends on the scope and on what already exists when we start. As planning ranges from our cost benchmarks: a single PCB layout takes 2–6 weeks per board and embedded firmware 4–16 weeks. A connected (IoT) product takes 3–12 months from concept to a production-ready design, and a regulated medical device 12–24 months to a 510(k) submission-ready package; from idea to mass production, a typical connected product takes 9–18 months. The proposal sets out a dated milestone plan, and you receive weekly progress updates during the project.
You do. Our contracts assign the intellectual property in the project work product (schematics, PCB design files, firmware source code and documentation) to you on payment, and we hand over the source files, not only fabrication outputs or compiled binaries. The exact terms are set out in the signed agreement for each engagement.
Yes. We sign a mutual NDA before any technical discussion of your project. Send your standard NDA or use ours; we return it signed within one business day.
Yes. We are based in Hyderabad, India, and work with product teams in India, the United States, the United Kingdom, Germany, Japan, Australia, the Middle East and other markets. Our office hours are 10:30–19:00 India Standard Time (UTC+5:30), Monday to Saturday, and we schedule design reviews across time zones, typically from US Pacific to Central European time. Japan is 3.5 hours ahead of India, so our first four hours overlap the Japanese afternoon. Prototypes and documentation ship by international courier such as DHL or FedEx. Our hardware outsourcing guide covers what to agree before an international project starts.
Yes. We prepare the manufacturing release package — fabrication and assembly drawings, the BOM with approved manufacturers, programming files and test specifications — and hand it over to the contract manufacturer (EMS) you choose. If you have not chosen one, we help you evaluate candidates through technical capability assessments and a pilot build. See manufacturing support.
No. Rapid Circuitry does not hold ISO 9001, ISO 13485 or other certificates. Our processes are aligned with ISO 9001:2015, and we design products to the requirements of the standards that apply to them — for example IEC 60601-1 and IEC 62304 for medical devices (with design documentation structured so your ISO 13485 quality system can absorb it) and IEC 61000 for EMC — and we specify IPC-A-610 workmanship classes for assembly. We prepare the product and its documentation for certification testing at accredited laboratories; the certificate or approval is issued for your product by the laboratory, notified body or regulator.
A short, non-confidential description of the product and what it must do (sensors, connectivity, on-device processing), the target production volume and unit cost, the markets and regulations it must meet (for example FDA, CE or FCC), your timeline, and what already exists: a concept, a proof of concept, schematics, PCB files or firmware. After the NDA, the next step is a 30-minute discovery call with the engineers who would work on the project, followed by the fixed-scope proposal. Send a project brief to begin.
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