Capacités de fabrication
CHS a établi une présence en tant que fabricant de dispositifs médicaux grâce à l'acquisition de Benlan Inc. en 1989. Les capacités initiales de l'entreprise étaient axées sur l'extrusion et les composants moulés. Depuis 1989, nos capacités ont considérablement évolué et nous avons étendu nos activités à l'emballage personnalisé et à l'assemblage de kits/plateaux.
Notre installation de 50 000 pieds carrés est stratégiquement située à Oakville, ON Canada, offrant un accès facile au marché canadien et au marché américain via le port d'entrée de Buffalo, NY pour servir de manière transparente les clients américains. Nous gérons quatre équipes de 12 heures sur une base 7x24 employant plus de 200 employés de production et de soutien à la fabrication (ingénierie, chaîne d'approvisionnement, qualité, RH/informatique).
L'usine de fabrication de classe mondiale de CHS dispose de 4 salles à environnement contrôlé (ECR). Chacune des salles est équipée de lignes de production d'emballages thermoformées automatisées qui sont opérées par des employés hautement qualifiés pour des processus manuels non automatisables. De plus, nous avons des capacités d'extrusion pour les exigences de qualité médicale et non médicale. CHS a institutionnalisé un processus efficace d'introduction de nouveaux produits (NPI) pour une montée en puissance rapide de la production qui comprend des intrants du client, des ventes, de l'ingénierie, de la fabrication et de la qualité.
CHS détient plusieurs certifications et licences nous permettant d'être un "guichet unique" pour tous vos besoins d'importation/exportation, de distribution et de fabrication.
Ceci comprend:
ISO 13485:2016 & MDSAP pour la fabrication au Canada et aux États-Unis
Enregistrement auprès de la FDA
Licence de site PSN pour l'importation
Licence d'établissement de médicaments pour l'importation
OEM Contract Manufacturing
CHS is experienced in a wide range of contract manufacturing services for strategic partners across the supply chain continuum. From OEM specialty components to custom sterile packaged products, CHS uses its capabilities to exceed the evolving needs of multiple industries. CHS will work closely with you to develop a unique package of services tailored to your requirements. This includes manufacturing, assembly, private label, packaging, regulatory consultation, and sterilization validation support. From design to delivery, CHS will provide cross functional experience and premium value at every step.
Our teams provide assistance with engineering and design, regulatory support (FDA and Health Canada), sterilization methods (gamma and ETO), material selection, as well as, document compliance. CHS provides smooth access to the Canadian market for manufacturers who do not have requisite MDSAP certification for Class II & above medical devices.
Our Facility is equipped to reliably provide any number of specialty and custom manufacturing solutions to complement your existing business and new opportunities. We extrude of a variety of custom tubing from high quality raw materials. We also have the capability to create custom molded components, as well as full white label solutions. CHS prides itself on the most agile and innovative solutions to suit your needs, in both medical and non-medical industries.
Custom Tubing Extrusion
CHS polymer extrusions and tubing provide solutions in almost any industry. Our OEM platform is built on ISO standards, high quality output, flexible scheduling, customized products and competitive global costs. CHS currently processes but is not limited to: PVC, HDPE & LDPE. We create a wide range of tubing sizes, wall thicknesses, tolerances and durometers that can be coiled or cut to suit your requirements. These products are a staple for the medical marketplace, and also encompass a wider variety of applications including automotive, food service and industrial custom solutions.
Molded Components
CHS provide a number of injection molded components for the OEM market including insufflation filters, suction connectors, Y-connectors, 400psi rated dual check valves, Yankauers, blue PVC feeding tube caps (5,6, & 8 fr), and acrylic thumb control valves.
Our component category offers fully integrated support for design, material selection, manufacturing, and production planning to meet your specific requirements. Covering a variety of colours and French sizes from 16-30, our tubing connectors ensure a tight and secure hold for full confidence in the medical setting. CHS ensures that regardless of industry or requirements, we are able to develop a customized solution.
We approach our molded components with the same level of detail that our customers are accustomed to from CHS. From design to delivery, you will work with your CHS representative to ensure that your specific needs are being met every step of the way.
Packaging & Assembly
CHS is positioned to develop a solution for any packaging need. We use adaptable automated assembly and packaging equipment including seven “form/fill/seal” and bagging machines. With state-of-the-art, high resolution, in-line printing capability, we offer customer specific labeling with excellent print quality on all types of packaging.
By choosing CHS, you are working with an OEM organization that combines 50+ years of medical, manufacturing, and service experience. We have an intrinsic understanding of clinical best practice. Our expertise in custom and specialty packaging allows us to help promote industry standards. CHS is vertically integrated - from tubing extrusion to local sterilization.
Packaging formats available
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Anesthesia Tray
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Standard Pouch
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Lidded Tray
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Bag
Quality & Regulatory
CHS is fully compliant with all Health Canada regulations and holds both a Medical Device Establishment License and Natural Health Products license. CHS has a deep understanding of the Canadian regulatory environment and has an experienced team ready to assist our suppliers with Health Canada requirements. Our regulatory compliance is a top priority and CHS is well known and respected by Health Canada.
Canadian Hospital Specialties has received the MDSAP certificate of registration. CHS is registered by Intertek, an MDSAP-recognized organization, as confirming to the requirements of ISO 13485:2016.