Why is ISO 13485 Important to me when buying a portable oxygen concentrator?
View our ISO13485 Certification (PDF) ISO 13485:2003 is a quality management system that is specific to organisations needing to demonstrate that they are able to supply medical devices and services that meet, not only customer requirements, but also the various regulatory demands relating to medical equipment. All requirements of ISO13485:2003 are specific to organisations providing medical devices, regardless of the type or size of the organisation. This means that all the quality management systems of Intermedical (UK) Ltd., our reporting systems, recall systems, servicing and repair procedures and our product traceability procedures are audited every year by BSI auditors. This ensures that each member of staff adheres to the necessary procedure to ensure that our clients receive product safe to use. Our clients can also be sure that we adhere to all of the regulatory requirements relative to the equipment we supply and potential clients should seek this certification as the minimum
