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Compliance Guides

Link Assistive is a registered supplier of Assistive Technology throughout New Zealand. The Ministry of Health may ask for the relevant assistive technology standards when approving assistive technology in your plan. Please find information below on Link Assistive products. Compliance documentation shows you the relevant standards that ensure the device conforms.

Tobii Dynavox

TD I-110

AS/NZS CISPR 11:2015
ISO14971:2007+2021


Indi 10

AS/NZS 60950.1:2015


I-13

ISO14971:2007


I-16

ISO14971:2007


TD Pilot

ISO 13585:2016


PC Eye 5

ISO 14971:2007+2012


AbleNet

AbleNet follows regulations outlined by different regulatory bodies worldwide. You can find further information here: https://www.ablenetinc.com/resources/regulatory-guiding-prinicples

Click here for the Declaration of Conformity for individual products.


Rehadapt

Rehadapt medical devices manufactured from May 26, 2021 will bear the CE-Marking. The Declarations of Conformity for these product families are available upon request.

ISO 13485:2016


Pretorian

ISO 9001:2015


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