Quality Medical Devices
The OxyArmTM is licensed under Health Canada, CE Marked for distribution in Europe and issued substantial equivalency from the FDA for distribution in the USA.
The OxyArmTM 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 100,000 Clean Room Assembly - Packaging - Distribution - Regulatory Affairs Support Services.
Certification
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.
Call us at 1-800-463-7146 toll free in North America or Complete the Contact Form.