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 USA 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 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 et réparation
Expert capital equipment setup, repair, and troubleshooting is provided via our in-house Biomedical Engineers.
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Minimiser les temps d’arrêt de l’équipement.
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Solves complex maintenance issues fast.
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Reliable, specialized support is always available.
Ventes et distribution spécialisées
Un réseau de distribution robuste avec quatre centres de distribution assure un fonctionnement 24 heures sur 24 et une sécurité des stocks.
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Mitigates supply chain insecurity.
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Eliminates logistical delays.
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Timely delivery of critical products.
Nos produits
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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Minimiser les temps d’arrêt de l’équipement.
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Solves complex maintenance issues fast.
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Reliable, specialized support is always available.
Perspectives cliniques et expertise dans l’industrie de la santé
Restez informé des dernières mises à jour sur la fabrication de dispositifs médicaux, la conformité réglementaire et les innovations en soins spécialisés.
Questions fréquemment posées
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 medical manufacturing capabilities does CHS offer?
We design and manufacture biomedical products and components with capabilities that include high-volume production, custom tooling, product development support, injection molding, extrusion, cleanroom manufacturing and OEM contract manufacturing.
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Does CHS provide OEM contract manufacturing?
Yes. We support OEM and contract manufacturing conversations for partners that need medical product or component production. We can discuss product requirements, feasibility, tooling, production scale, documentation needs, quality expectations and project management support.
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How does vertical integration improve product supply?
Vertical integration gives us more control over materials, production processes, quality checks, availability and delivery planning for applicable products. For healthcare customers, this can reduce supply uncertainty and support more consistent access to critical products or components.
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Can CHS support custom tooling or product development?
Yes. For appropriate projects, our team can discuss custom tooling, design for manufacturing, product development, production planning and manufacturing feasibility.
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How should partners start a manufacturing project with CHS?
Partners should contact us with product requirements, drawings or specifications, target volumes, regulatory considerations, intended use, timeline and packaging needs. We can then review the opportunity and recommend the next step for development, quoting or production planning.
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