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Southmedic Inc.

50 Alliance Blvd.
Barrie, ON L4M 5K3 Canada
Tel: 705/726-9383
Fax: 705/728-9537

Web: http://www.medicalmanufacturing.ca
E-mail: mlavimodiere@southmedic.on.ca


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Southmedic is a Canadian national medical device manufacturer and distributor of surgical specialty products.

Medical manufacturing, contract manufacturing, certified clean room injection molding and clean room assembly

We were founded in 1982 and consists of 3 divisions:

  1. Proprietary products (medical manufacturing of our own products)
  2. Distribution (specialty medical devices shipped globally)
  3. Clean room medical manufacturing (concept, design, tooling, molding, assembly and packaging) for our customers products

Southmedic's Domestic Division is one of the largest independent distributors of operating room products in Canada with a dynamic and efficient sales force from coast to coast. We specialize in selling surgical and specialty operating room products that require in-service. Emphasizing customer service, we focus on providing the technical support and knowledge that is essential to you.

Southmedic is a vertically integrated custom manufacturing facility, which specializes in Cleanroom Injection Molding of medical components. The design team provides state of the art 3D solid modeling capabilities. Our approach guarantees rapid delivery and cost effective tooling. A certified Class 100,000 clean room houses modern injection molding machines ranging from 35 to 300 tons. Controlled environment assembly facilities are also available.

Being a medical manufacturer, we understand the compliance issues and the regulatory side of medical manufacturing and can assist you in your medical device manufacturing. As your 13485 certified FDA, SGS and CE registered supplier, Southmedic can handle all aspects of your project whether it be a contract manufacturing plant transfer situation or a new program. Our team of highly trained engineers and QA/Regulatory associates can convert your medical device concept into a reality. Southmedic keeps all its projects on time and on budget by using APQP (Advanced Product Quality Planning) and PPD (Product Process Development).

Why choose Southmedic as your medical manufacturer? That's easy - with our quality, innovation and speed to market you will find us to be your supplier of choice. We offer a full gamut of services from concept and design, tool, molding, assembly, and final packaging. Our 60,000 sq ft facility specializes in certified cleanroom molding and assembly.

Manufacturing Capabilities

  • Program Management: Advanced Product Quality Planning (APQP) ensures that communication with customers and suppliers is clear and allows us to facilitate a smooth and timely implementation.
  • Design Engineering: Capabilities include product design, proof of concept, project management, industrial design, risk analysis and design verification/validation, CAD and solid modeling, design for manufacturability, ISO 13485 including design control, engineering change/part revision control, mold flow analysis, PFMEA, fixture design, DMM, and DFA.
  • Tooling: Precision tool manufacturing capability, projection management, engineering change/part revision control, cost control/job tracking, prototype to multicavity tooling, cold runner, hot runner, insert molds, fixture build.
  • Injection Molding: Class 100,000 cleanroom injection molding, computer controlled closed-loop machines, servo-driven robots at machines for post-mold operations, color feeders, centralized chiller system, centralized vacuum loading and drying system eliminates possibility of particulates contaminating our cleanroom, digital mold heaters with thermocouple, insert molding, over molding, SPC( statistical process control), scientific molding, mold maintenance, DOE (design of experiment)
  • Assembly and Packaging: Class 100,000 assembly room, device assembly, production control, sonic welding, pad printing, tray and pouch sealing for sterile and non-sterile devices, thermoforming, heat sealing, heat staking, solvent bonding, UV bonding.
  • Sterilization: Southmedic staff carefully consider the many factors in selecting the most appropriate method of sterilization for your product. Sterilization can be achieved via dry heat, steam, gaseous chemicals or irradiation and each method must first be considered relative to the compatibility of the material.

    • Supply Chain Management
    Our team is focused on reducing cost, improving quality and delivery times, implementing lean manufacturing process improvement methodologies. In addition, we provide full service supply chain management with an experienced and responsive team to complement every aspect of manufacturing, custom injection molding and business needs.

    Regulatory
    Southmedic recognizes that regulatory compliance is an essential requirement in the medical device industry and achieved initial certification to ISO standards in 1996. When you choose Southmedic as your OEM supplier, you are selecting a supplier that is:

    ISO-13485 Certified

    SGS Registered

    FDA Registered

    CE Registered

    We can provide the necessary support in determining the regulatory requirements of your product whether determining device classification, guiding 510k documentation, conducting risk analysis or assessing post-market considerations. Southmedic offers a comprehensive analysis of requirements.

    ISO 13485:2003, MDD 93/42/EEC Annex II (European Medical Device Directive), CMDCAS (Health Canada's Medical Device Conformity Assessment System).

    Core competencies include: Design - Tooling - Cleanroom Injection Molding - Class 10,000 and 100,000 Clean Room Assembly - Packaging - Distribution - Regulatory Affairs Support Services.

    On-Line Customer Support Centre
    We are proud to be a leading Canadian manufacturer and distributor of a wide range of medical devices. Customer Service is our #1 priority. Southmedic's territory managers are professionally trained, resulting in expert inservicing capabilities in both the operating room and out patient procedural areas.


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