Medical Devices

Medical Devices: Quick Scan for Beginners relating to ISO 13485

Motivation and benefits

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).
Target group

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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    Our expert

    Impartial. Competent. Trustworthy.

    Network partner

    Mr. Andreas Aichinger, MSc

    Network partner, Product Expert Medical devices ISO 13485

    +43 732 34 23 22