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13485 Certified and FDA Registered
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).
All raw materials are sourced in the USA and Europe. All manufacturing is conducted at the Amparo Medical factory in Placentia, CA, USA.
ISO 13485 Certified & FDA Registered
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.