Not all CDMOs are built for complex devices. When your partner lacks deep device expertise, you end up teaching them, managing multiple vendors, and fixing preventable mistakes. Sonele eliminates that risk with true technical depth: ➡️ Precision fabrication, machining, and microelectronics integration ➡️ Expertise in sterilization, biocompatibility, and regulatory compliance ➡️ Proven processes for complex assembly and medical-grade testing ➡️ An understanding of high-tech device requirements from day one We deliver tailored solutions that shorten timelines, reduce risk, and improve performance. Don’t pay for someone else’s learning curve. Work with a partner who already understands your technology. #MedicalDevices #MedTech #MedicalManufacturing #HealthcareInnovation
Sonele Inc.
Medical Device
Markham, Ontario 1,686 followers
Maximizing Success of Medical Devices through World-Class Manufacturing
About us
Sonele Inc. specializes in medical device development and manufacturing within an ISO 13485 & FDA Registered Facility. Our expertise and experience in medical device development and commercialization include all stages of product-to-market and provide a unique ability to get necessary technologies into consumers' hands. We have extensive and successful experience in supply chain management, creating and expanding manufacturing lines for new and existing products, assembly and packaging, and international distribution. Sonele's ultrasound division supplies medical and industrial ultrasound transducers backed by proprietary technology that offers significant advantages in performance and reliability.
- Website
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http://www.sonele.com
External link for Sonele Inc.
- Industry
- Medical Device
- Company size
- 11-50 employees
- Headquarters
- Markham, Ontario
- Type
- Privately Held
- Specialties
- Medical Devices, Ultrasound, and Transducer Fabrication
Locations
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Primary
Get directions
46 Riviera Dr
Markham, Ontario L3R, CA
Employees at Sonele Inc.
Updates
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Launching your product is just the beginning. Where many manufacturers step back, Sonele stays involved. We provide ongoing technical support, refine devices using real-world data, manage lifecycle changes, and guide you through shifting regulations. Our commitment doesn’t end at delivery. We remain a partner as your technology grows, adapts, and meets new market demands. If long-term support is what your device needs, let’s connect. #MedicalDevices #MedTech #MedicalManufacturing #HealthcareInnovation
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Strong partnerships are the foundation of breakthrough devices. We’re grateful to have worked alongside Chris Bass and the team at InventoRR MD - AbClo to make AbClo a reality. Their trust in Sonele’s design and manufacturing expertise made this collaboration a success. Here’s to building more breakthroughs together. #MedicalDevices #MedTech #MedicalManufacturing #HealthcareInnovation
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Medical devices aren’t consumer gadgets. An electrical fault in a phone is an inconvenience. In a clinical setting, it can put patient safety at risk. Our engineering team designs systems specifically for medical applications. Every build is optimized for reliability, compliance, and scalability. The result is a device that performs in clinical environments where precision matters most. Partner with Sonele for electrical systems built to meet true medical-grade standards. #MedicalDevices #MedTech #MedicalManufacturing #HealthcareInnovation
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23 years of building what others said couldn’t be done. Since 2002, Sonele has transformed complex concepts into market-ready devices. Along the way, we’ve earned ISO 13485 certification, FDA registration, and decades of trust from startups, researchers, and OEMs. Our history is defined by challenges solved, processes refined, and lasting partnerships that make innovation possible. Let’s build the next milestone together. #MedicalDevices #MedTech #HealthcareInnovation #MedicalInnovation
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Outsourcing everything introduces risk. Making everything in-house slows you down. The smartest path is balance. At Sonele, we combine in-house precision with strategic supplier partnerships, ensuring you get control where it matters most, and reliability everywhere else. It’s a make-vs.-buy strategy designed specifically for medical device manufacturing. #MedicalDevices #MedTech #MedicalManufacturing #HealthcareInnovation
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Poor documentation today means regulatory rejection tomorrow. Even the most innovative medical device won’t move forward if regulators can’t follow your development process. Gaps in design history, validation reports, or testing documentation can add months or years to your launch timeline. At Sonele, we build documentation that regulators trust: ➡️ Detailed design history files showing systematic development ➡️ Validation reports (IQ, OQ, PQ) proving manufacturing consistency ➡️ Risk assessments and testing records aligned with standards ➡️ Full traceability that supports compliance requirements Don’t let paperwork stall your breakthrough. Let’s build the right foundation together. #MedicalDevices #MedTech #MedicalManufacturing #HealthcareInnovation
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The shipment that never arrived just moved your deadline. In medical device manufacturing, testing, validation, and even market launch can be delayed by one missed delivery. Sonele doesn’t leave supply chain reliability to chance. Our team actively manages vendor relationships, builds redundancy into sourcing, and maintains critical safety stock so your production line isn’t held hostage by missing parts. That means your device moves forward on schedule, even when the market doesn’t cooperate. Looking for a partner who prioritizes keeping your supply chain steady and your timelines intact? Let’s talk. #MedicalDevices #MedTech #MedicalManufacturing #HealthcareInnovation
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Big things are happening here. As Sonele grows, we’re adding new talent to keep pace with the breakthroughs our partners are bringing to market. We’re looking for people who get excited about solving complex problems, tinkering with precision tech, and helping turn bold medical device ideas into reality. Right now, we’re hiring for: 🔹 Engineering Project Lead 🔹 Senior Process Engineer - Ultrasound Manufacturing 🔹 Ultrasound Transducer R&D Engineer 🔹 Lead Electrical Systems Engineer 🔹 Senior Electrical Engineer 🔹 Quality Engineer 🔹 Quality Assurance Specialist And more! If you thrive on collaboration, care about details, and want your work to help move an industry forward, let’s talk. #MedicalDevices #MedTech #HealthcareInnovation #MedicalInnovation
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Even the most advanced medical technology can fail if clinicians and patients can't use it effectively. Poor industrial design creates hidden costs: frustrated users, training delays, and devices that gather dust instead of saving lives. At Sonele, our medical device designers focus on human factors engineering: ➡️ Ergonomic, user-friendly designs optimized for clinical use ➡️ Intuitive interfaces that require minimal training and enhance safety ➡️ Form factors that fit real clinical workflows and market expectations ➡️ Designs that improve adoption rates through ease of use The best technology means nothing if healthcare professionals won't use it. We ensure your innovation works in the real world, where every interaction matters. Don't let poor design kill your breakthrough technology. Contact us to discuss how human-centered design can maximize your device's impact. #MedicalDevices #MedTech #HealthcareInnovation #MedicalInnovation
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