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Product user experience and risk based thinking implemented into processes are essentials for medical device success. Labquality can support with the process creation and through the whole usability process.

Usability - standards & guidances

There are several standards and guidances which partially overlap each other. Labquality experts can assist you over the full spectrum of usability activities starting from creating a processes in the QMS through creating usability engineering file for your device including all the necessary formative and summative testings.  Usability activities are mandatory.

Usability have its own standard for medical devices (IEC 62366-1) and it is in the harmonisation list for MDR and IVDR and in the recognised consensus standard list of US FDA. This standard requires risk based approach and a certain set of documentation for each usability engineering file. Risk based approach is also in the core of this standard. Usability thinking and efforts should be started as early as possible to understand what users need and want.

IEC 62366-1 focuses on identification and mitigation of use related risks and encourages for great user experience. Also ISO 14971 risk management standard covers usability aspects and these standard cross reference to each others. IEC/TR 62366-2 provides additional guidance and explanation for 62366-1 but does not contain any requirements.

For medical electric devices, IEC 60601-1-6 provides additional usability considerations.

ANSI/AAMI HE75 is not recognised in the EU but is in the US FDA recognised consensus standard list. This is recommended reading and understanding for anyone working with medical device usability.

US FDA provides guidance document for medical device usability but there is none in EU. MDR, IVDR and some MDCG guidances refer to usability efforts.

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How can we help?

Labquality can support in following activities and documents

  • usability engineering process
  • full usability engineering file for medical device
  • formative test plans and reports
  • summative test plan and report
  • usability risk analysis
Meeri Säily

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Meeri Säily
Sales Manager

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