ISO 13485:2016 & MDSAP
Certification for medical device manufacturing in both Canada and the United States.
Vertically Integrated Production
Our manufacturing process is controlled end-to-end, guaranteeing quality and supply certainty for the products made.
50+ Years of Expertise
Long-standing manufacturing stability and specialized sector knowledge in biomedical manufacturing and distribution.
FDA Registration
Our registration with the U.S. Food and Drug Administration ensures that our manufacturing processes and products are compliant for the US market.
Drug Establishment License
Importing drug components into Canada supports the overall manufacturing operation by securing the supply of necessary raw materials.
NHP Site License for Importing
Our certification for the importation of Natural Health Products further diversifies the compliant scope of CHS’s manufacturing operation.
Our vertically integrated, ISO-certified manufacturing solves core supply chain insecurity and product quality risks for clinic and hospital procurement teams and clinicians.
CHS' Core Manufacturing Capabilities
CHS supports high-volume, high-precision medical component production with vertically-integrated capabilities, ensuring superior quality, compliance, and absolute supply certainty for your critical product lines.
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OEM Manufacturing
Dedicated service for private label and contract manufacturing of biomedical products and components.
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Comprehensive design and product development processes. -
High-volume production capacity. -
End-to-end project management.
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Engineering & Tooling
In-house engineering teams manage custom tooling, design for manufacturing (DFM), and all product development cycles.
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Custom tooling and mold design. -
Design for Manufacturing (DFM) consultation. -
In-house CAD/CAM support and technical drawing.
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Certifications & Compliance
We actively maintain all required licenses and registrations to ensure every product we manufacture is compliant for its intended market.
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ISO 13485:2016 & MDSAP certification. -
Active FDA and Health Canada registrations.
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Drug and NHP import licensing management.
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Quality Management System
Our controlled quality system ensures full compliance, clinical certainty, and traceability for every product manufactured.
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Product licensing and technical guidance.
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In-house quality testing laboratory.
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Production Facility & Scale
Specialized production facilities, including cleanroom environments, are engineered for superior component quality and reliable supply.
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ISO-8 Cleanroom manufacturing.
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Vertically integrated process.
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Robust production scale.
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Core Production Technologies
Specialized production lines are dedicated to high-precision component manufacturing and processing.
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Injection moulding and extrusion lines.
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Automation and process control.
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Precision assembly and final packaging.
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Customer Service
Responsive technical and logistics support is dedicated to the unique requirements of your manufacturing project.
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Client support and project managers.
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Bilingual (French/English) service .
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Escalation procedures for critical issues.
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Service & Repair
Expert capital equipment setup, repair, and troubleshooting is provided via our in-house Biomedical Engineers.
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Minimized equipment downtimes.
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Solves complex maintenance issues fast.
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Reliable, specialized support is always available.
Speciality Sales & Distribution
A robust distribution network with four distribution centres ensures 24-hour operation and inventory security.
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Mitigates supply chain insecurity.
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Eliminates logistical delays.
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Timely delivery of critical products.
Our Products
CHS provides specialized technical service for high-value clinical equipment, ensuring maximum operational uptime and preserving the continuity of patient treatment.
Top Benefits of In-House Technical Service:
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Minimized equipment downtimes.
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Solves complex maintenance issues fast.
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Reliable, specialized support is always available.
Clinical Insights and Healthcare Industry Expertise
Stay informed with the latest updates on medical device manufacturing, regulatory compliance, and innovations in specialty care.
Frequently Asked Questions
Review answers to common questions regarding our manufacturing process, compliance, lead times, quality standards, and customization capabilities. This detailed resource supports technical inquiries and procurement due diligence.
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What is the benefit of CHS's vertically integrated manufacturing process?
Vertical integration provides end-to-end control over the production process, from raw materials to final product. This ensures superior quality, complete traceability, and absolute supply certainty for critical components.
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Does CHS offer custom tooling and product development?
Yes. Our in-house engineering teams manage custom tooling, Design for Manufacturing (DFM) consultation, and all aspects of the product development cycle for our partners.
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What production scale does CHS support?
Our facility is engineered for high-volume, high-precision medical component production, backed by dedicated injection moulding, extrusion lines, and robust capacity planning.
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What is CHS's core quality certification for manufacturing?
We maintain ISO 13485:2016 certification for medical device manufacturing, ensuring clinical certainty and rigorous quality management across all production processes.
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How does CHS handle regulatory compliance for contract partners?
We actively manage all required licenses, including active FDA and Health Canada registrations, and provide expert guidance on product licensing to mitigate regulatory risk for our partners.
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Does CHS have a cleanroom environment?
Yes. Our facility includes an ISO-8 Cleanroom manufacturing environment for specialized, high-precision component production, ensuring product integrity.
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Can CHS manage the supply chain for materials used in my product?
Yes. Our internal supply chain management, supported by our import licenses (including Drug Establishment and NHP Site Licenses), ensures a secure and compliant source for all necessary raw materials and components.
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Who is my point of contact for a manufacturing project?
Each project is assigned dedicated client support and specialized project managers who serve as the primary point of contact for all technical, production, and logistics inquiries.
Get Started with Certainty
Request a quote, ask a technical question, or speak with a specialist about your supply chain needs.
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