Quality management is essential for our success and yours
Our quality assurance system allows us to deliver products that you can count on. We know that trust is essential to any clinician/patient relationship. Our research, manufacturing and operational standards ensure that when you reach for a Scion BioMedical product, it performs to the standard required.
Scion's products are manufactured in rigorously controlled ISO Class 7 cleanrooms in fully validated processes. Our product design and manufacturing activities are performed in compliance with U.S. FDA cGMP Quality System Regulations, European Union Medical Device Directive (MDD) and the Canadian Medical Device Regulations (CMDR), the most stringent medical device regulations in the world.
All supplies and materials are carefully tested and inspected prior to use. Focused quality control points throughout the process, prove that the quality and safety are maintained. The final product is inspected and tested prior to release. This ensures the quality of all of our products.
Our certifications include:
ISO 13485:2003 – design, manufacture and distribution of non-woven hydrophilic wound dressings (download)
EC Type-Examination – Class III non-woven hydrophilic wound dressings (download)
CE Marking of Conformity – Non-Woven Hydrophilic Wound Dressings (download)
To find out more about our quality control processes or to receive a sample of our products please contact us at 866.259.8881 / firstname.lastname@example.org