Cothera, a global medical device manufacturer, has announced that it has received ISO 13485:2012 certification.
This independent certification validates Cothera’s long-standing commitment to quality, and affirms that Cothera’s quality management system provides a solid foundation for its medical device initiatives.
The ISO 13485 certification covers the design and development, production and distribution of Cothera’s medical devices including its flagship product, the VPULSE system. The certification demonstrates that Cothera has successfully implemented a quality management system that conforms to certain worldwide standards for medical device and diagnostic manufacturing.
Cothera general manager Howard Edelman said that as an early-stage medical device company, ISO 13485 certification represents a significant growth milestone.
"This designation, along with our recently awarded CE Mark, recognizes Cothera’s commitment to provide our customers with outstanding, high quality products and broadens our path to increase international sales," Edelman added.
The VPULSE system combines deep vein thrombosis (DVT) prevention and post-procedure rehabilitation, and places effective therapies and significant convenience in the hands of patients. DVT is among the most frequent hospital-acquired conditions.
Though many professional associations and hospitals have developed protocols designed to prevent DVT and PE (pulmonary embolism), until now there hasn’t been an economically feasible medical device that transitions from hospital to home use thus allowing for continued patient compliance. Given the majority of DVT episodes occur post-discharge, the VPULSE System is available to help hospitals control readmission-related costs, while supporting clinician treatment plans.