 |
|
The OxyArm™
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™ 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. |
|
|
