Amparo Medical Technologies

Quality &
Accreditation

Quality Policy

We will develop, manufacture and distribute safe and effective products. We will ensure quality meets meticulous regulatory compliance and will strive to exceed customer expectations and continuously monitor the effectiveness of the Quality Management System (QMS).

ISO 13485 Accreditation

Amparo’s Quality Management System is accredited with BSI ensuring compliance to ISO
13485:2016.

REACH/RoHS/PROP 65

Amparo’s products are compliant with the EU regulations for REACH and RoHS as well as California’s regulations for PROP 65.

Biocompatibility

Amparo’s base hydrocolloid formulations are tested for biocompatibility and are compliant with ISO 10993.

Testing Lab

Amparo’s Testing Lab conducts 100% verification for all products manufactured certifying specifications are met.

Request a consultation
converter guide