Download certificates

Here you can find all current Auditdata Management System Certificates such as ISO 27001 and EC plus Declarations of Conformity for all our products and solutions.

Management System Certificates

ISO 27001

ISO 27001 Certificate

ISO 13485

Auditdata A/S ISO 13485 Certificate
Auditdata A/S ISO 13485 MDSAP Certificate

EC Certificates

Auditdata A/S EC Certificate 93-42-EEC MDD Annex II

Product Certificates

Declarations of Conformity

AuditBase clinic management system
Primus PFU Fitting unit
Primus PHITU Hearing instrument test unit
Primus HIT Pro Hearing instrument test unit
Primus PFU+ Fitting unit Plus
Primus PFU Pro Fitting unit Pro
Primus Ice audiometer
Primus Video Otoscope
Entomed SA201 audiometer
Entomed SA202 audiometer
Entomed SA203 audiometer
Entomed SA204 audiometer
Entomed TY-101 tympanometer
OTOPod MI, M2 audiometer


Health Canada

Primus Hit Unit
OTOPod M1 audiometer
OTOPod M2 audiometer
Primus Ice Audiometer
Primus Pro Fitting Unit Pro
Primus HIT hearing instrument test unit
Entomed SA-series audiometers
Primus Video Otoscope

Questions about security?

If you have any questions as to how we handle information and keep our – and your – data safe, please get in touch.

Dan Haugbøl
Director corporate QA/RA and IT/information security

+45 70 20 31 24

Strato data protection

For more information on Strato data protection, please go to the article on Strato security.

AuditBase compliance

For more information on AuditBase compliance, please go to the AuditBase compliance page.

Auditdata cookie policy

For more information on our cookie policy, please read our guidelines here.

All you need to know. You are in safe hands.
Compliance and security