Our quality assurance commitment

ISO 9001:2000 & ISO 13485:2003

Every batch manufactured at our state-of-the-art production facility undergoes a full QC analysis before shipping. A Certificate of Analysis documents the findings and is sent with every order. Plus, a sample is archived along with the corresponding production record for traceability purposes. Beyond these self-directed QC protocols, we also embrace and employ the practices and principles endorsed by the International Organization for Standardization (ISO). Currently we hold ISO 9001:2000 and ISO 13485: 2003 certifications. We have maintained these certifications since 1997 through over 100 audits of our Quality System by both third party auditors (such as our ISO registrar KEMA as well as numerous customer audit teams) and internal audits. Copies of our certificates are available to customers on request.