Patient-centered design
Intuitive interfaces, non-intrusive monitoring and integration into daily routines, for higher compliance rates and more effective care.
Industries
We engineer connected-care systems that move reliable device data into clinical workflows: remote patient monitoring, secure medical-device integration, telehealth applications, hospital asset tracking and health-data pipelines. Teams building the regulated device itself can use our medical device development program for electronics, firmware, safety and design-control work.
Definition
Healthcare IoT (also called the Internet of Medical Things, or IoMT) is the network of connected medical devices, biosensors, and clinical systems that collect and exchange patient data in real time. Rapid Circuitry designs hardware documented for FDA 510(k) submissions, IEC 62304 firmware, and data pipelines designed to support HIPAA Security Rule safeguards (encryption, access control, audit logging) for remote patient monitoring, hospital asset tracking, and connected diagnostics — engineered with medical-grade PCB design (IPC-2221/2222 design, IPC-6012 and IPC-A-610 Class 2/3 build), ultra-low-power embedded hardware, and on-device edge AI.
What we build
Biosensor integration with edge AI processing for real-time vital signs monitoring, medication adherence tracking, and continuous health assessment through medical-grade wearables.
Machine learning that analyzes patient data to predict health trends, detect early warning signs, and help clinicians act before complications become critical.
Connectivity between medical devices, EHR systems, and healthcare platforms using HL7 FHIR standards and custom APIs, with multi-device synchronization for comprehensive patient monitoring.
End-to-end encryption, secure authentication and audit trails that protect patient data in transmission and storage, designed to support your HIPAA Security Rule and GDPR obligations.
Optimized BLE, LoRaWAN, and cellular connectivity implementations that extend battery life for wearable devices while maintaining reliable data transmission in healthcare environments.
Edge processing that enables real-time analysis of patient data at the source, reducing latency for critical alerts and minimizing bandwidth requirements for continuous monitoring.
Custom telehealth solutions with integrated video conferencing, secure messaging, and remote diagnostic capabilities, enabling healthcare providers to deliver care regardless of patient location.
Intuitive, customizable dashboards that visualize patient data trends, treatment effectiveness, and operational metrics, enabling data-driven decision making for healthcare providers.
Documentation and verification support for FDA submissions and CE (EU MDR) technical files, and for your ISO 13485 QMS audits, including verification test records and validation protocols.
Expertise
Our team develops medical devices designed to IEC 62304 and ISO 13485 requirements and healthcare systems designed for HIPAA-regulated deployments, combining biomedical sensors, edge AI processing, secure data transmission and regulatory documentation.
Intuitive interfaces, non-intrusive monitoring and integration into daily routines, for higher compliance rates and more effective care.
Power management and efficient data processing to extend battery life for wearable devices, enabling long-term continuous monitoring.
Hardware-level security features, encrypted data storage, secure boot processes, and comprehensive access controls to protect patient information.
HL7 FHIR, DICOM and other healthcare data standards for integration with EHR systems, hospital information systems and third-party platforms.
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
Wearable EEG Headset
Japanese neurotech startup
Smart IV Infusion Pump
Medical-device company, India
Oral Screening Camera Probe
Medical-device client, India
Neonatal Vitals Wearable
Medical-device client, India
FAQ
We design to, and document for: FDA 21 CFR Part 820 (the Quality Management System Regulation, which incorporates ISO 13485:2016 by reference), ISO 13485:2016 design-and-development requirements, IEC 62304 (medical device software lifecycle), IEC 60601-1 (medical electrical equipment safety), the HIPAA Security Rule safeguards your organisation must meet, and CE marking under the EU MDR (Regulation (EU) 2017/745). Rapid Circuitry holds no certificates; the documentation is structured so your QMS and regulatory team can absorb it.
We work on Class I and II devices and on Class III subsystems under the sponsor's QMS. For these we implement risk management per ISO 14971, design and development controls per ISO 13485:2016 clause 7.3 as required by the QMSR, and verification/validation testing. We prepare engineering documentation for 510(k) submissions, can support a sponsor's PMA, and work with your regulatory affairs team throughout the process.
We design architectures that support your HIPAA Security Rule safeguards: encryption at rest and in transit (AES-256, TLS 1.3), role-based access control, audit logging, secure authentication and data minimisation. Each design goes through a security risk assessment whose records can feed your own HIPAA risk analysis. HIPAA has no product certification; compliance stays with the covered entity or business associate.
We integrate various biosensors: PPG for heart rate and SpO2, ECG for cardiac monitoring, temperature sensors (contact and infrared), accelerometers/gyroscopes for activity and fall detection, bioimpedance for body composition, and glucose monitoring interfaces. Sensor fusion algorithms combine multiple inputs for improved accuracy and reliability.
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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