The European Medical Device Regulation 2017/745 (MDR) came into force on 26th May 2021, replacing the Medical Device Directive (MDD).

Quha Zono and Zono 2 were classified as Class I medical devices according to the MDD. Quha has taken all the necessary steps to ensure compliance with the more rigorous requirements of the new regulation. The Quha Zono and Quha Zono 2 mice continue to be classified as Class I medical devices under the MDR. The devices have been officially registered to the local regulatory authority for medical devices Finnish Medicines Agency.

All Quha Zono and Quha Zono 2 products delivered by Quha since today are official MDR medical devices.

Medical device distributors also have new responsibilities under the MDR. The MDR distributor obligations are listed on the European Commission’s Factsheet for Authorised Representatives, Importers and Distributors of medical devices and in vitro diagnostic medical devices.

View and download the Declarations of Conformity for Quha Zono and Quha Zono 2 via the links below:

Declaration of Conformity for Quha Zono
Declaration of Conformity for Quha Zono 2

MDR compliant user manuals are available here.

Contact Quha for more information.

Quha will be hosting four 30-minute webinars during spring 2021:

1. Quha Vento launch
   Feb 16th, 2020 at 9.00 CET
2. Zono vs Zono 2
   Mar 18th, 2020 at 9.00 CET
3. Gaming with a head mouse
   Apr 15th, 2020 at 9.00 CET
4. Working with a head mouse
   May 20th, 2021 at 9.00 CET

Registration is now open. Please register on our events webpage. Welcome!

In the first webinar we will be launching a new Quha product, the Vento puff switch. If you have any questions about the webinars, please contact us.

Quha is a Finnish company who designs and manufactures electronic assistive technology computer access products. Quha’s products are used to access computers and mobile devices by people with special needs.

Quha’s most known products are wireless gyroscopic computer head mice Quha Zono and Quha Zono 2 that allow computer use without hands. They are known for providing superior accuracy, great compatibility and easiness to their users. Additionally, Quha manufactures mouse accessories, ability switches and software.

We are proud to annouce that Quha has become a member of DATEurope, the newly launched Digital Assistive Technology Industry Association for Europe. DATEurope’s mission is to unite the Digital Assistive Technology industry across Europe to influence legislation, awareness, sustainability, growth and commerce.

Quha is a Finnish company who designs and manufactures electronic assistive technology computer access products. Quha’s products are used to access computers and mobile devices by people with special needs.

Quha’s most known products are wireless gyroscopic computer head mice Quha Zono and Quha Zono 2 that allow computer use without hands. They are known for providing superior accuracy, great compatibility and easiness to their users. Additionally, Quha manufactures mouse accessories, ability switches and software.

Samu Vesa started as Quha’s new Key Account Manager at the beginning of January 2021. His main responsibilities are customer account development and increasing product awareness. Samu holds a master’s degree from Tampere University of Technology and has a versatile background with experience in in R&D, production technology, customer interface management and account management. We are very pleased to welcome him to our team!

Quha is a Finnish company who designs and manufactures electronic assistive technology computer access products. Quha’s products are used to access computers and mobile devices by people with special needs.

Quha’s most known products are wireless gyroscopic computer head mice Quha Zono and Quha Zono 2 that allow computer use without hands. They are known for providing superior accuracy, great compatibility and easiness to their users. Additionally, Quha manufactures mouse accessories, ability switches and software.