Many organizations are thinking about starting to be active in the field of medical instrumentation. As a rule, these organizations are subcontractors and do not want to put any medical devices of their own into circulation, in this phase. Nevertheless, system certification should be striven for in connection with this project, helping organizations to stand out against their competitors.
In order to give these organizations, which have, in most cases, already established a quality management system, an overview of requirements of ISO 13485 that have already been implemented or are still open, Quality Austria offers the Quick-Scan for Beginners relating to ISO 13485. This is a short audit that serves to systematically review and assess the extent to which the requirements of the Standard are met. The Quick Scan will also dedicate a speical focus on the requirements of ISO 13485.
- reviewing against requirements relating to medical devices (ISO 13485).
Any organizations that would like to start to be active in the field of medical instrumentation and establish a relevant management system or adapt their existing quality management systems.
At this short audit, the extent to which all the requirements of ISO 13485 are met will be reviewed.
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