Skip to content


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 & guidance

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

Usability has 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 the US FDA. This standard requires a risk-based approach and a certain set of documentation for each usability engineering file. A risk-based approach is also at 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 the identification and mitigation of use-related risks and encourages great user experience. Also, ISO 14971 risk management standard covers usability aspects and these standards cross-reference each other. 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 documents for medical device usability but there is none in the EU. MDR, IVDR and some MDCG guidances refer to usability efforts.

labquality-frame-blue (1)


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

Contact us for more information

Meeri Säily
Sales Manager

Leave a contact request

Related Services

Latest news

20/09/23 12:09

Meet us at BCLF 2023

Labquality’s international sales team will be available for meetings at the XXX Meeting of the Balkan Clinical Laboratory Federation on 27-30 September 2023 in Montenegro.
Read more
06/09/23 09:00

Data management in clinical investigations - Part 4: Statistical considerations for pivotal investigations

Medical device manufacturers planning their first pivotal premarket investigations for CE-marking benefit greatly from early collaboration with statistics professionals and an understanding of statistical principles. We offer data management, biostatistics and data protection services as part of the wider CRO clinical investigations offering.
Read more
05/09/23 07:19

Meet us at ECP in Dublin!

Labquality will be attending the 35th European Congress of Pathology on 9-13 September in Dublin.
Read more
01/09/23 12:30

Welcome to Labquality Days 2024!

The scientific program for Labquality Days 2024 has been launched and registration is now open!
Read more
30/06/23 15:02

New pilot studies announced!

We have four EQA pilot studies coming up after the summer holidays! The arranged pilots will be free of charge for a limited number of participants.
Read more

Subscribe to our newsletter

Subscribe to hear the latest news in the industry and keep track of what's happening behind the scenes.