Design hardware that gives your software a signal it can trust.
We partner with your engineers on electrode design, materials selection, ECG electronic schematic, PCB design, mechanical design, and a test strategy that proves the whole front end is ready.
From wearables and patches to clothing-integrated devices, we help you capture cleaner ECG and bioimpedance signals that exceed the ISO electrical test requirements, so the algorithm, study and regulatory work that follows is built on solid ground.
98.9% / 99.8%
QRS sensitivity and specificity for upper arm dry electrode ECG against Holter referenceDe-risk signal quality before it slows the whole programme down.
Inside ABEL, we pressure-test the sensing stack early, uncover the limitations that derail ECG programmes, and help your team move forward with evidence instead of assumptions.
From concepting to pre-FDA testing and validation.
Deploy proven ECG algorithms without building the stack from scratch.
HeartKey® is our FDA 510(k)-cleared algorithm suite for dry or wet electrodes, spot-check or continuous monitoring, and on-device or cloud deployment. It gives device manufacturers a faster route to high-confidence features, backed by proven performance and designed to fit real product constraints.
98.3% / 100%
Sensitivity and specificity for AF detection from 30-second wrist ECGsStrengthen your clinical and regulatory path with a team that has done it before.
From preclinical study design and Quality Management Systems to 510(k) strategy, we support the decisions that turn a promising prototype into a product that can stand up in review. We work as a practical extension of your team, not advisors at arm’s length.
>20
Partner engagements with consumer wearable, medical wearable and ambulatory monitoring companies, and hospital systems
ISO 13485
Quality management systems for the design and manufacture of medical devices.
IEC/ISO 62304
Software lifecycle processes for medical device software, from planning through release.
IEC 82304-1
General requirements for the safety and security of health software products.
ISO 14971
Application of risk management to medical devices across the product lifecycle.
Professional Services Packages
Most customer requirements fit within one or more of the following three packages — each with defined scope, a clear outcome, and an indicative timeline. If yours doesn’t, that’s fine — we have extensive experience designing bespoke programmes around specific needs.
ECG Assess
Covers Stage 1
Stage 1:
ECG Design & Regulatory Assessment
- Regulatory pre-compliance assessment
- Analog front end (AFE) & signal-chain review
- Schematic, PCB layout & BOM review
- Electrode material & coating review
Clear design and regulatory plan
ECG Prove
Covers Stages 1-2
Stage 2:
Prototype Eval & Pre-Compliance
- ECG signal-quality testing on prototypes
- Benchmarking vs B-Secur references
- IEC 60601-2-47 pre-compliance testing
- Clinical validation strategy & planning
Signal quality proven on real prototypes and clinical strategy mapped
ECG Complete
Covers stages 1-5
Stage 3-5:
Clinical, Integration & Submission
- Clinical study design & execution
- Human factors study & reporting
- HeartKey® software integration & testing
- CE / FDA submission-ready technical file
A submission-ready ECG solution, end to end
Cumulative packages, each tailored to your programme. Programme discounts apply vs. purchasing stages individually.
* Timings can vary depending on several factors, including scope, prototype readiness, and clinical study design.
Wherever you are in the pathway,
we can help move your product forward.
Most of our partnerships start with a thirty minute call between one of our engineers and one of yours. No slides. No generic pitch. Just a clear discussion about the sensing, software or regulatory challenge in front of you.