SAN CLEMENTE, Calif., February 21, 2019 (Newswire.com) - Spinal Singularity has received ISO 13485:2016 certification. ISO 13485 is an international standard that sets the requirements for a comprehensive quality management system for the design and manufacture of safe and effective medical devices. High levels of safety and quality are non-negotiables in the medical device industry with regulatory requirements becoming increasingly stringent throughout every step of the product’s lifecycle.
ISO 13485 certification is the first step in demonstrating conformance with European regulatory requirements and is mandatory to allow entry of Spinal Singularity products into the European community.
“Completion of our initial certification audit with zero findings and receipt of ISO 13485:2016 certification confirms the dedication and commitment of our entire staff to develop and maintain an effective Quality Management System,” said Bill Colone, CEO.
Director of Quality, Stephanie Rallis, commented, “Our team is very proud of accomplishing this milestone as it not only demonstrates our commitment to quality and meeting customer and regulatory requirements; it furthers our mission of providing medical devices that may exponentially improve the quality of life for our users.”
About Spinal Singularity, Inc.
Spinal Singularity, developer and manufacturer of products to improve the quality of life for individuals living with spinal injury. The company has developed an innovative, smart catheter system Connected Catheter System, currently in a multi-center evaluation study in the United States. The Connected Catheter is the first fully internal, smart catheter system for adult males with Urinary Retention.
Additional information about the clinical study can be accessed on Clinical Trials.gov.
Visit www.spinalsingularity.com for more information about the company and the Connected Catheter System.
The Connected Catheter System is currently an INVESTIGATIONAL DEVICE ONLY and Limited by Federal (or United States) law to investigational use.
105 Avenida De La Estrella, Suite 3
San Clemente, CA 92672 USA
+1 (949) 436-7974
Source: Spinal Singularity