Quality

The OxyArm^TM is licensed under Health Canada, CE Marked for distribution in Europe and issued substantial eqivalency from the FDA for distribution in the USA.

The OxyArm^TM device is assembled in a controlled environment to assure the utmost cleanliness and quality in its manufacture.

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), 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.

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.