Medical Product Development Services​

Timelines vary based on device complexity, regulatory requirements, and manufacturing considerations. The full device design development process typically takes 2-7+ years, with Class I (low-risk, exempt from 510(k)) projects taking closer to 2+ years and Class III (PMA, high risk, implantables, novel devices requiring clinical trials) projects taking closer to 5-7+ years.

Sonele operates under a certified ISO 13485 Quality Management System (QMS) for medical device development and contract manufacturing. Our structured quality process helps identify complex problems early, while maintaining the documentation and traceability required throughout development.

As a full-service medical device product development company, Sonele has extensive experience developing ultrasound imaging systems and probes, surgical devices, diagnostic devices, therapeutic systems, medical software, and health IT.

Scaling is built into the process rather than treated as a separate phase. Design for Manufacturability is applied from the earliest concept work, so the same design that passes verification testing moves into full production at Sonele’s manufacturing facility, without a redesign cycle in between. Project management runs continuously throughout that transition, preventing a program from stalling at the handoff between prototype and manufacturing.

User research is worked into the process well before a device reaches formal validation. Early observation and feedback from the people who’ll actually operate the device, whether that’s a clinician or a patient at home, surface use error risks while changes are still inexpensive to make. That groundwork feeds directly into the human factors documentation regulators expect to see, and it’s also where much of the practical improvement in patient and caregiver well-being comes from: a device that’s easy to use the first time correctly.

Sonele operates as an ISO 13485-certified, FDA-registered manufacturer, and regulatory support is one of the seven stages built into every program, covering FDA, Health Canada, and CE Mark pathways. Bringing that regulatory work into engineering, rather than after the fact, is what actually de-risks a program: issues that would otherwise surface during a submission review get caught during design, when they’re far cheaper to fix.

Sonele’s medical product development services span diagnostic imaging, surgical devices, and therapeutic systems, which puts the team’s experience across a range of therapeutic areas within life science rather than a single clinical niche. That breadth is useful for companies whose devices need to perform across multiple use settings or patient populations, since the underlying engineering questions tend to recur even when the clinical application changes.

Firms like NOVO Engineering operate as broad solutions providers across consumer products, industrial equipment, and other markets outside life science. Sonele specializes exclusively in medical devices, combining that focus with in-house, ISO 13485-certified manufacturing. This means your product can move from development to production under one roof—without the added complexity of transitioning to a separate contract manufacturer.

Sonele’s team brings more than two decades of medical device engineering experience. That history includes ISO 13485 certification in 2015, FDA registration in 2016, and a first customer FDA clearance the same year, which is the kind of track record that matters when a company is choosing a partner to carry a device from concept through a regulatory submission.