Quality Medical Devices Southmedic Quality Medical Devices

Quality Medical Devices

Southmedic specializes in the manufacturing of products for the medical and electronic industries. We have earned a worldwide reputation for quality, product design and innovation in the manufacturing of medical anaesthetic components.  In December 2006, Southmedic was registered by SGS for certification to:

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

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

Certification

FM 643600 – ISO 13485 CMDCAS

CE 644824 – Annex V

CE 644823 – Annex II

 

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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
  • FDA Registered
  • CE Registered

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