Certifications
DIFRA is certified to the requirements of ISO 13485:2003 and has Medical CE-mark
DIFRA is certified to the requirements of ISO 9001:2000 and ISO 13485:2003 by the notified body SGS (identification no. 1639)
Medical CE-mark:
The CE-mark indicates that Instrumentation DIFRA meets the requirements of Annex II of the Medical Device Directive 93/42/EEC. Approval is made by SGS identification no. 1639
TGA approval:
For the Australian market, Instrumentation DIFRA has TGA approval for all the product line.
FDA approuval:
For the USA market, our vestibular line is FDA approved.