Arch Therapeutics, Inc., developer of the AC5 Surgical Hemostatic Device, recently announced that it has received an internationally recognized ISO quality certification, marking completion of a critical step for Arch in its plans to commercialize AC5.
The certification, which was awarded by British Standards Institution Group America, Inc., attests that the Company’s quality management system complies with the requirements of ISO 13485:2003 for the design and manufacture of AC5 for hemostasis. ISO 13485 is a quality management system standard accepted as the basis for CE marking medical devices under European Directives.
ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. Receipt of the certification is a regulatory requirement that needs to be fulfilled before a medical device may be commercialized in the EU.
Dr. Terrence Norchi, President and CEO of Arch, stated, “Obtaining this certification is an important milestone and an essential component of Arch’s strategy to obtain CE marking for our first product and patented technology. It is the culmination of a tremendous effort aimed at fulfilling consumer requirements, and resulting from the implementation and execution of improvements to our quality management systems. As previously disclosed, we have started to prepare a dossier of information for our CE marking application, which we intend to file this summer.”