Now in a brand new 30,000 sq. ft. facility. Same trusted service, greater capacity to support your next breakthrough.
CDMO Medical Devices
Smarter, faster manufacturing for high-performance medical products
You’re building a medical device where precision, reliability, and performance matter every time. Sonele provides end-to-end CDMO services to help you move your product forward with greater speed and confidence.
90%
Projects include direct design and engineering input
<8 Weeks
Average turnaround for first-article prototypes
10-1K+/month
Flexible and scalable production capacity for complex builds
50+
Countries where client devices are in use today
Let’s turn your breakthrough idea into a product ready to scale
You’ve invested the resources into developing a high-performing medical device. Now you need a manufacturing partner that can turn your vision into a product ready to scale.
Sonele combines technical expertise and precision manufacturing to help medical device OEMs keep driving innovation without compromising quality. Whether you’re building your first clinical units or preparing for large-scale production, our team works closely with yours from our 30,000 sq. ft. facility built specifically for medical device manufacturing.
Chris Bass, CEO
InventoRR MD
“It has been great working with Sonele. Their team has been extremely responsive and helpful in working with us to design AbClo into the great product it is today.”
A better partner for CDMO services
Catch problems before they reach production
Our team brings materials expertise to refine designs, tolerances, and processes early on, helping prevent costly setbacks later.
Engineers in your corner
Work directly with an experienced team that understands your technical goals and what it takes to achieve them.
Collaboration with fewer handoffs
With integrated engineering and advanced manufacturing under one roof, we keep timelines tight and quality consistent.
Built for MedTech quality
Strong quality systems, full traceability, and regulatory expertise help you scale with confidence from clinical builds through commercial manufacturing.
Advanced medical device manufacturing to take your product further
Automated test and inspection
Our in-house acoustic, mechanical, and electrical test platforms provide complete traceability and data logging. Some of our capabilities include mechanical failure testing, thermal cycling, high-potential (hi-pot) and patient leakage tests, custom test scripts with matching fixtures, and full regulatory safety compliance.
Epoxy and adhesive handling
Sonele provides controlled dispensing of high-performance adhesives using UV, thermal, and dual-cure workflows. Our materials expertise supports structural integrity, electrical reliability, biocompatibility, and repeated sterilization.
Full-system electromechanical integration
We assemble and test complete CDMO medical devices incorporating sensors, PCBs, displays, batteries, motors, wireless modules, and other electronic components. We also support custom enclosures, sterile/non-sterile packaging, product labeling, and software integration for connected systems.
Custom tooling and fixturing
We design and fabricate precision assembly and test fixtures around your product’s geometry and production requirements.
Simulation and tolerance analysis
Finite Element Analysis (FEA) and tolerance analysis help identify performance and manufacturability before the prototype is built.
Ultrasound transducer and stack expertise
We supply and integrate single-element, linear, and 2D ultrasound arrays backed by deep experience in acoustic stack design and performance.
High-precision microfabrication
Our advanced manufacturing includes micron-level machining, lapping, grinding, dicing, and 3D laser micromachining to produce tight-tolerance components.
How our end-to-end CDMO services support your product lifecycle:
R&D + Proof of Concept
Reduce early-stage uncertainty by validating your concept before committing to full development.
- Our medical product developers use feasibility studies and technology validation to address technical challenges early.
- Our data-driven testing and engineering insights help you move into full-scale development with greater confidence.
Medical Device Prototyping
Turn your device into a high-fidelity prototype you can test and improve.
- We evaluate form, function, and performance before finalizing the design.
- We accelerate iteration with quick-turnaround prototypes to gather stakeholder feedback.
Electrical & Mechanical Engineering
Build your device for reliable performance and scalable medical device manufacturing.
- Our engineers resolve integration challenges early to reduce downstream production risks.
- We design with efficiency, cost, and scalability in mind so your device is ready when production volume increases.
Software & Firmware Development
Optimize functionality, connectivity, and control for real-world performance.
- We develop custom embedded software tailored for precision control and regulatory compliance.
- We can integrate wireless connectivity, AI-powered diagnostics, and cloud-based data solutions for connected CDMO medical devices and digital health applications.
Industrial Design
Create a device that works for the people who will actually use it.
- Our medical device designers focus on human factors engineering to improve usability, ergonomics, safety, and the overall user experience.
- We consider how the device will be used in real clinical or patient environments while balancing the practical requirements of medical device manufacturing.
Regulatory Support
Build regulatory readiness to help your product reach the market faster.
- Our team helps you navigate regulatory complexities by identifying the testing protocols and documentation requirements for approval (FDA, Health Canada, CE Mark).
- We support your regulatory strategy with detailed design history files, risk assessments, process validation reports, testing documentation, and rigorous quality and traceability standards.
Component Fabrication
Gain greater control over the components that are key to performance.
- We manufacture critical components in-house or source them through qualified suppliers based on your medical device requirements.
- Our high-quality fabrication processes support the tight tolerances, specialized materials, and repeatability expected in medical device manufacturing.
Supply Chain Management
Keep production on track with supply chain resilience built for growth.
- We maintain operational excellence by helping you avoid supplier disruptions, material shortages, and unexpected costs.
- We manage supplier relationships, procurement, and inventory planning so the right materials are available when you need them.
Process Validation
Make sure your manufacturing process can deliver consistent results.
- We conduct detailed process validation (IQ, OQ, PQ) for guaranteed quality assurance at every step.
Device Assembly & Testing
Built to exact specifications with precision assembly.
- Our controlled manufacturing environments and documented medical device assembly processes support consistent production in line with ISO 13485 and FDA guidelines.
- Our CDMO medical devices undergo functional and performance testing against defined specifications before release.
Packaging & Labeling
Move from finished production to market-ready product with fewer downstream delays.
- We align packaging materials, sterilization compatibility, and labeling with global medical device regulations (FDA, CE, MDR, etc.).
Sterilization Management
Streamline the reprocessing workflow while meeting sterility assurance level (SAL) targets.
- We coordinate sterilization processes and validation support (ETO, gamma, e-beam, or steam sterilization).
Stocking & Distribution
Keep products readily available while minimizing excess inventory through tailored stocking and distribution.
- Our stocking, warehousing, and delivery support helps reduce lead times and maintain product availability as demand changes.
Frequently asked questions
Earlier than you think. Involving a medical device contract manufacturing organization during the initial concept development or early rapid prototyping phase helps prevent manufacturability issues and accelerate your path to market launch. Our interdisciplinary teams take a proactive approach, connecting design, engineering, and smart manufacturing from day one.
Yes. We work closely with medical device original equipment manufacturers (OEMs) on DFM, tolerance analysis, and material selection to address potential risks early in the product lifecycle. That means less rework, cost advantages, and a more reliable manufacturing process. It’s part of how we integrate medical device development into a complete, comprehensive solution.
Absolutely. We specialize in medical device contract development and manufacturing for high-mix, mid- to high-volume production, supporting everything from early feasibility builds and clinical units through full commercial production and technology transfer. Our manufacturing organization is equipped to evolve with your product, ensuring consistency and quality through every phase.
We manufacture a broad range of complex systems for the medical device industry, including:
- Surgical Devices & Interventional Devices
- Diagnostic Systems
- Medical Consoles & Instrumentation
- Wearables & Wireless Devices
- Robotic & Mechatronic Systems
Our strengths lie in building complex components to tight tolerances, integrating advanced technologies, and delivering high-performance assemblies that support the full product lifecycle.
Yes. Our CDMO device manufacturing services apply a global supply chain management approach to procurement, inventory management, supplier coordination, and global logistics. Bringing these activities together reduces reliance on multiple external partners and lets your internal team stay focused on development, clinical priorities, and commercialization.
We follow robust quality control protocols and ensure full traceability, aligning with ISO 13485 principles. Our understanding of regulatory affairs and challenges means we can help your product meet global regulations for patient safety, even in complex, multi-step manufacturing processes. We take pride in our specialized expertise and commitment to excellence.
Yes. From clinical trials to commercial manufacturing, Sonele’s end-to-end CDMO services support capacity expansion. Our 30,000 sq. ft. facility and scalable core competencies enable us to transition from pilot runs to high-volume production while maintaining quality, compliance, and flexibility.
The medical device CDMO market is crowded, so look beyond capacity alone. Key trends include growing healthcare investments, demand for end-to-end CDMO services, and greater need for global supply chain management, regulatory expertise, and technical expertise across areas such as digital health and drug-device combination products. Sonele brings these capabilities together with certified quality systems and capacity designed to scale—giving you one CDMO partner built to keep pace with the market.
Sterilization requirements vary by device class and material, so we manage this as part of process validation, coordinating with qualified sterilization partners (EtO, gamma, or e-beam, depending on your product) and validating the sterilization cycle in your device master record. We handle the logistics and documentation so that sterilization is built into your production timeline, not an afterthought.
Our role centers on manufacturing compliance: ISO 13485 processes, design controls, DHF/DMR documentation, and traceability that support your submission. We’re not a regulatory consultancy, but our documentation and process validation work is built to align directly with what you’ll need for a 510(k), PMA, or international equivalent, and we coordinate closely with your regulatory team or outside consultants throughout the project.
No. Sonele does not manufacture combination products or drug-device combination products. Our expertise is in the development and manufacturing of complex CDMO medical devices, where we provide deeper engineering, quality, and production support throughout the product lifecycle.
Sonele does not manufacture fully finished active implantable devices, such as pacemakers or cochlear implants. We do, however, manufacture diagnostic, therapeutic, surgical, and minimally invasive medical devices, including external and procedural ultrasound technologies used alongside other MedTech systems.
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