25 years of quality
ONSA Medical’s China team is made up of fifteen people specialised in quality control of medical equipment and textiles. These areas of expertise are invaluable as surgical masks and personal protective masks are precisely composed of synthetic textiles.
The quality control team has been working with Swiss and European clients for more than 25 years, and are perfectly acquainted with the level of excellence required of the products. As part of their responsibilities, they inspect the factories, check certifications and monitor the production lines.
Our Chinese suppliers have been manufacturing disposable medical equipment for many years. All are listed amongst the Chinese companies authorised to export, as decided by the Chinese government in April 2020.
The Quality Management System maintained by all our manufacturers is registered to ISO 9001 Quality Management System Requirements. Our medical devices manufacturers are certified in accordance to ISO 13485.
Our manufacturers maintain a quality management system as an integral part of their CE marking process.
CE MARKING AND PRODUCT CONFORMANCE
All our products are CE marked.
Products classified as Personal Protective Equipment, such as FFP2 masks, are produced in line with the requirements of EU Regulation 2016/425, and type examined and tested to the standard EN 149.
Products classified as Medical Devices, such as surgical masks, are produced in line with the requirements of EU Directive 93/42/EEC or Regulation 2017/745, and type examined and tested to the standard EN 14683.
It is only after meeting the requirements of the relevant EU regulation or directive and of the relevant EN Standard that the products are CE marked.
In addition, certain products also conform to other non-European standards (for example USA or China conformance).
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