Medical Product Quality Certification

DRI Sleeper® alarms are designed and manufactured in New Zealand by Anzacare Limited and are registered as, and compliant with, medical device regulations in USA, Canada, UK, Europe, Australia and New Zealand.

Anzacare management systems are independently assessed and certified annually by SAI Global as meeting the internationally recognized standards of ISO13485:2003 for design and manufacture of medical devices. SAI Global is the world’s leading certification company recognised as global benchmark for quality and integrity. 

Anzacare was the first manufacturer of bedwetting treatment alarms to have attained this certification and this shows our commitment to quality above everything else.

The essence of the ISO 13485:2003  certification is recognition that Anzacare constantly meets customer and regulatory requirements as a medical device designer and manufacturer. 

Have a look at the detail of what this actually means to you, the customer, by downloading more information on the ISO 13485:2003 standard and what this means for your new DRI Sleeper® alarm. 

Lydia and her girls

My daughter loves the alarm. She’s told me to ‘sell my pull-ups on eBay mommy’. She just loves that she doesn’t have to wear pull-ups…

- Lydia Du Buisson