MEDICAL
MONITORING &
DIAGNOSTICS
IEC 60601-1 hardware, IEC 62304 firmware, ISO 14971 risk management, and full regulatory support — built as a discipline, not an afterthought.
The Engineering Problem
Medical Device Development Is a Regulated Engineering Discipline
Treating compliance as a final-step checklist collapses under FDA scrutiny or Notified Body review. It must be designed in from the first schematic, the first requirements document, the first line of firmware.
IEC 60601-1 defines architecture — isolation, means of patient protection, leakage budgets that affect every component choice. IEC 62304 changes how firmware is written; ISO 14971 threads through every design decision. These aren't overhead — they are the design methodology.
Our engineers carry regulatory context as internalized knowledge — IEC 60601-1, IEC 62304, and ISO 14971 are working constraints, not references to look up. Your design history file is built correctly from day one, and the rework that kills most timelines never happens.
Medical Device Categories We Build
From wearable patches to laboratory instruments — we engineer the hardware across the full spectrum of medical electronics.
Vital Signs Monitoring
Cardiac Monitoring Devices
Point-of-Care Diagnostics
Drug Delivery & Infusion Electronics
Remote Patient Monitoring
Surgical & Procedural Instruments
Rehabilitation & Neurostimulation
Laboratory & Analytical Instruments
IEC 60601-1 Hardware Design
Patient-applied part isolation, means of patient protection (MOPP/MOOP), leakage current budgeting, and applied part classification from the first schematic.
IEC 62304 Firmware Development
Software class B and C development lifecycle — requirements traceability, unit testing, integration testing, anomaly resolution, and complete software documentation.
Clinical Sensor Accuracy
Analog front-end design for ECG, SpO2, NIBP, blood glucose, and bioimpedance — signal conditioning, noise rejection, and clinical accuracy validation against reference standards.
ISO 14971 Risk Management
Hazard analysis, risk estimation, risk control measures, and residual risk evaluation integrated throughout development — not assembled at the end.
Regulatory DHF Preparation
Design history file assembly aligned with FDA 21 CFR Part 820, 510(k) technical sections, CE Technical Documentation, and IVDR/MDR compliance packages.
Wireless in Medical Devices
BLE, Wi-Fi, cellular (LTE-M/CAT-M1), and 802.15.4 wireless integration with FDA cybersecurity guidance compliance, authentication, and encrypted data transport.
Biocompatibility & Materials
ISO 10993 biocompatibility guidance for patient-contact materials, skin-contact adhesive selection, and sterilization-compatible component choices.
Manufacturing & QMS
ISO 13485 design transfer documentation, production test specifications, incoming inspection criteria, and post-market surveillance system design.
Chipsets & Platforms
Platforms & Standards
Tested silicon and proven stacks — no experimental platform dependencies.
Vital Signs & Cardiac Monitoring
Precision bioelectrical signal acquisition from the skin surface — the hardest analog problem in medicine.
The ECG front end defines why medical analog design differs from any other domain — microvolts riding on body potentials that swing hundreds of millivolts, with power-line interference orders of magnitude larger than the signal. Our front ends use right-leg drive, >80 dB CMRR differential stages, per-lead contact monitoring, and IEC 60601-2-25 compliance from prototype. These aren't textbook problems — we've solved them in production hardware.
Point-of-Care Diagnostics & Drug Delivery
Quantitative measurement and precise delivery — two sides of the same closed-loop challenge.
Lateral flow readers need quantitative output from a format designed for qualitative readout — our spectrally-matched optical front ends extract a ratiometric result corrected for membrane variability and traceable to calibration standards. Infusion pump electronics mirror that challenge: dual-channel pressure sensing, sub-microliter stepper encoder feedback, and firmware that treats every sensor disagreement as a patient safety event.
Why Medical Device Companies Choose Ankh Innovations
Compliance Is Our Design Methodology
Our engineers design with IEC 60601-1, IEC 62304, and ISO 14971 as primary constraints — not retrofitted at the end. Regulatory documentation is built correctly from day one.
Clinical Accuracy From the Analog Stage
We've designed ECG front ends at >80 dB CMRR, SpO2 circuits to ISO 80601-2-61, and NIBP oscillometric algorithms validated against auscultatory reference. Clinical accuracy is an engineering outcome.
Patient Safety as a Design Constraint
Every device we touch has patients at the other end. That gravity runs through every design review — defibrillator protection, alert hierarchy, battery chemistry selection in worn devices.
Medical Cybersecurity Built In
Threat modeling, authenticated OTA updates, encrypted storage, and vulnerability disclosure processes are built in from the start — so your 510(k) cybersecurity section is complete, not scrambled together at submission.
Continuous RPM Vital Signs Patch
A digital health company needed a disposable 7-day vital signs patch — ECG, SpO2, temperature, accelerometer — in a 42 × 28 × 6 mm body with 180 mAh battery life and FDA 510(k) Class II clearance.
Dual-die SiP (analog front end + MCU, 4.2 × 3.2 mm) with a 30 μA monitoring / sub-1 μA idle state machine. Flex PCB under 1 mm integrates electrodes, optical sensors, and BLE antenna. IEC 62304 Class B lifecycle applied from the first commit.
- 7.3-day continuous operation on target battery
- ECG signal quality meeting AHA ambulatory ECG standards
- 510(k) cleared in 11 months from design start
- Automated production test in <90 seconds per unit
Quantitative Lateral Flow Analyzer
An IVD company needed quantitative cardiac biomarker results (Troponin I, BNP) from lateral flow strips — existing semi-quantitative readers showed >15% CV, unacceptable for cardiac rule-out. Target: <5% CV traceable to NIST.
Spectrally matched 630 nm optical system with TIA front end and dual-wavelength ratiometric algorithm correcting for membrane lot variability. Thermistor temperature compensation and three-point factory calibration per lot reduced systematic bias. IVDR-compliant firmware lifecycle applied throughout.
- 3.2% median CV across 20 cartridge lots
- Quantitative results equivalent to lab analyzer within ±15% for Troponin I at decision threshold
- CE IVDR Class B IVD technical file completed
- 60-second time-to-result from cartridge insertion
Engineering Your Medical Device?
From IEC 60601-1 analog design to 510(k) submission support — we build medical electronics the right way, from the first schematic.
Quote Your Medical Device Project