Now in a brand new 30,000 sq. ft. facility. Same trusted service, greater capacity to support your next breakthrough.
Medical Device Contract Manufacturing
Next-generation devices, made possible by next-level manufacturing
Bring your innovative high-tech medical device to market faster, more affordably, and with superior performance.
Let’s ensure your innovations reach patients when they need them most.
Transforming patient outcomes with groundbreaking medical devices starts with choosing the right manufacturing partner.
We take pride in providing long-term end-to-end medical manufacturing support that scales according to demand, reduces prohibitive costs, and fast-tracks production timelines, putting transformational technology in the hands of healthcare professionals faster.
Randy AuCoin
Exact Imaging President and CEO
“Sonele immediately understood where we were coming from with our product concept. More importantly, they knew where it needed to go and how to get it there.”
A better partner for manufacturing medical devices
Lower costs
From saving you money on costly third-party components to helping you reduce inventory holding costs, we are committed to making the production process as cost-efficient as possible.
Faster time to market
Ensure your product reaches patients and healthcare professionals faster due to our proven experience, advanced manufacturing capabilities, and specialized tools.
Long-term partnership
We take pride in building long-term strategic partnerships. Beyond product development and manufacturing, we adapt to evolving market demands and regulatory changes, ensuring sustainable success and innovation in the medical field.
Scalable manufacturing
We have the capacity and agility to scale quickly, ensuring high-quality, cost-efficient manufacturing that can seamlessly adapt to growing demand without compromising delivery timelines.
How we transform your blueprint into a transformational medical device
01
Component Fabrication
Get tighter control over quality, performance, and cost, avoiding inconsistencies from third-party suppliers.
- We manufacture critical components in-house or work with trusted suppliers to ensure reliability and compliance.
- Our high-precision, high-quality fabrication processes are tailored to medical device requirements.
02
Supply Chain Management
Avoid supply chain disruptions, material shortages, and unexpected costs, ensuring smooth production scaling.
- We manage vendor relationships, procurement, and inventory to ensure on-time availability of high-quality materials.
03
Process Validation
Gain confidence in consistent product performance and regulatory compliance from the start.
- We conduct detailed process validation (IQ, OQ, PQ) to guarantee that every step meets regulatory and quality standards.
- We guarantee repeatable and reliable manufacturing processes.
04
Device Assembly & Testing
Ensure precision assembly with rigorous quality control and testing.
- Our controlled manufacturing environments ensure high-quality assembly, meeting strict ISO 13485 and FDA guidelines.
- Every device undergoes functional and performance testing to verify compliance with specifications before release.
05
Packaging & Labeling
Receive ready-to-ship devices in compliant packaging, reducing post-manufacturing processing time.
- We ensure packaging materials, sterilization compatibility, and labeling meet global regulatory standards (FDA, CE, MDR, etc.).
06
Sterilization Management
Avoid complex sterilization logistics while ensuring compliance with sterility assurance level (SAL) requirements.
- We coordinate sterilization processes (i.e. ETO, gamma, e-beam, or steam sterilization) with qualified partners and manage process validation.
07
Stocking & Distribution
Reduce inventory holding costs, lead times, and supply chain risks, allowing for faster market response.
- We offer stocking, warehousing, and delivery, ensuring devices are available when needed.
Frequently asked questions
Costs can vary widely depending on the complexity of the device, the materials required, and the volume of units ordered. Please contact us for a detailed quote based on your specific project requirements.
Sonele operates under a certified ISO 13485 Quality Management System (QMS) for medical device development and contract manufacturing.
Sonele has extensive experience manufacturing high-tech medical devices, including diagnostic, therapeutic, surgical and minimally invasive devices, among others.
At Sonele, we have a flexible and scalable manufacturing approach designed to accommodate increasing production volumes efficiently while maintaining the highest quality standards. Our ability to scale depends on several factors, but in general, we can ramp up production within weeks to months, depending on the complexity of the device and supply chain considerations.
Here are a few of the ways that we ensure scalability is baked into our processes:
- We have a highly trained team and we can quickly onboard additional operators and technicians as needed.
- We implement automation, robotics, and lean manufacturing practices to help us increase efficiency while maintaining consistent quality.
- We can accommodate additional shifts and extended production hours for urgent high-volume demands.
- We closely collaborate with suppliers to anticipate demand and reduce lead times.
- Our strategic inventory management ensures we have safety stock for critical components.
- Our team actively mitigates supply chain risks to support rapid scale-up.
- All manufacturing scale-ups follow strict process validation (IQ, OQ, PQ) to ensure regulatory compliance.
- We maintain electronic Device History Records (DHRs) and Quality Management Systems (QMS) to streamline production.
We are pleased to host our clients at our facility for site visits, issue resolution, new product builds, direct engagement with our team, and more.
Yes, we provide ongoing technical support, troubleshooting, product refinement, and lifecycle management. We’re your long-term partner every step of the way.
At Sonele, we believe in open communication and keeping our customers informed at every stage—from concept to commercialization. Our customers receive detailed project roadmaps with clear milestones and real-time progress updates, and we provide full transparency in pricing, project timelines, and manufacturing processes.
Contact Us
Ready to push the boundaries of medical technology?
The future of healthcare innovation starts here.
Fill out the form, and we will contact you within 3-5 days to start the process of bringing your breakthrough technology to life.
