Your medical ideas, transformed into reliable & compliant devices.
Electronic health products
Developing a medical device is both exciting and complex. Regulations, technical risks, clinical validation… every detail matters.
Motsai designs and secures the electronic components of your portable medical devices. We transform your ideas into reliable, compliant solutions that fit seamlessly into your product strategy.
Your market is growing
The global market for connected medical devices and healthcare IoT is projected to grow from USD 81.4B in 2023 to USD 349.9B by 2033, with a 15.7% CAGR.
From connected medical wearables to miniature surgical tools, we’ve contributed to projects that combine performance, miniaturization, and seamless integration.
Movement analysis
Highly precise sensors that track, understand, and improve every movement.
Inflatable smart garment
Neurotechnologies & Data Analysis
Turning brain and physiological activity into actionable insights.
Brain training systems
HOP Watch V4
HOP Technologies.
Medical wearables
Miniaturized sensors for continuous, connected health monitoring.
A hand temperature regulation device.
Specialized medical watches
Biometric shirts (ECG, respiration)
Surgical Tools / Medical Accessories / Medical Training
Integrated electronics that enhance surgical precision and safety.
Sanitary dispenser monitoring system
An electronic surgical tool
A 3D intuitive robot-control interface
With Motsai, compliance becomes a built-in strength at every step.
During the design phase, every step is fully documented, risks are thoroughly analyzed, and all critical parameters — including data security, electromagnetic compatibility and IoT-related requirements — are validated to ensure your device is reliable and compliant from the outset.
During the manufacturing phase, we help you select partners who guarantee complete traceability and support you throughout the processes required to meet the exact requirements of all applicable ISO and IEC standards.
We rely on specialized partners who deeply understand international standards and medical regulations: ISO 13485 – ISO 14971 – IEC 62304 – IEC 60601 – IEC 62366.
The result is validated, reliable, certifiable electronics.
But with us, it's different.
Whether you’re a startup, SME, or R&D team, we accelerate your electronic development and simplify your path to market. We clarify every step of the electronic development process.
By Your Side
Ready to bring your idea to life?
Your wearable concepts turned into connected, ready-to-use products.
Your smart home ideas converted into secure, reliable products.
From idea to factory: your industrial project executed with rigor and expertise.
Innovation never stops — and neither does Motsai.
We have supported projects involving Class I and Class II medical devices. Our approach covers architecture, design, and testing with compliance in mind from day one. We work closely with specialized regulatory partners and your team to structure a realistic path to certification, reducing risk and delays at each stage. While Motsai does not currently hold ISO 13485 certification, our development process is structured to produce documentation and traceability records compatible with a client’s or partner’s certified QMS. We understand what a compliant technical file requires, and we build toward it.
Yes. We design sensing systems and develop algorithms for motion analysis, biometric tracking, and real-time signal processing. Our focus is the architecture, design, and technical compliance side. Determining the clinical validity of any medical claim remains the customer’s responsibility, and we structure our engagement accordingly.
Timelines vary significantly, and in medical device development, that variation is rarely small. As a rough guide, Class I devices typically require 18 to 24 months from concept to market readiness, while Class II devices commonly run 24 to 36 months or longer.
Complexity, regulatory pathway, and the depth of safety and performance documentation all shape the schedule in ways that are difficult to compress. Unlike consumer electronics, medical products go through structured phases including safety analysis, clinical performance substantiation, and end-to-end production traceability, all for good reason, and none of these can be shortcut. Standards such as IEC 62304 for software lifecycle and IEC 60601-1 for electrical safety introduce defined development and verification requirements that must be planned for, not retrofitted.
Our role is to keep the engineering track moving as efficiently as possible within that framework, so delays on the technical side do not compound the ones already inherent to the process.
Yes, though the nature of that help is worth clarifying from the start. Motsai covers the engineering side: feasibility, electronic architecture, prototyping, validation, and preparation for industrialization. We do not provide clinical validation or medical performance assessment. That expertise needs to come from the client’s organization or their designated medical partners.
What this also means in practice is that the medical concept itself, its rationale, intended use, and demonstrated efficacy, needs to be established before we can engineer a meaningful path toward certification. We bring structure and momentum to the technical track, as part of a broader team that includes medical and regulatory specialists.
By addressing feasibility, budget, and compliance together from the beginning rather than treating them as sequential concerns. The most expensive problems in medical device development are usually ones that were visible early but deferred: architecture decisions made without regulatory context, or cost assumptions built on a consumer product model applied to a medical one.
One of the more common risks we flag proactively is scope drift. A connected wearable that gradually accumulates health-related claims can find itself subject to regulatory requirements it was never designed to meet. If a device is worn by or attached to a patient, it will almost always be classified as a medical device, regardless of how the project originated. Attempting to sustain borderline health claims under a consumer product label carries real regulatory exposure.
It is also worth being precise about what constitutes a medical claim. A casual observation that a sensor output correlates with a health outcome is not a medical claim until it has been clinically demonstrated and peer-reviewed. We help clients understand where that line sits before they commit to a product architecture or a market position, because changing course after the fact is significantly more costly than getting the framing right from the start.
