D Medical Industries' subsidiary Spring-Set Health Solutions (formerly Medx- Set Ltd), a designer and marketer of Universal Detach Detect Infusion Sets, has achieved ISO 13485:2003 and ISO 9001:2008 certifications.
In order to obtain the certification, Spring-Set demonstrated the ability to consistently meet strict requirements for Quality Management Systems (QMS) applicable to medical device manufacturing and related services.
ISO 9001:2008 focuses on defining customer quality requirements, use of data to analyze the processes, meeting applicable customer and regulatory requirements, enhancing customer satisfaction and continually improving business performance.
D Medical CEO Efri Argaman said the achievement of both ISO 13485:2003 and ISO 9001:2008 certifications demonstrates their continued commitment to the highest levels of quality management and design controls to ensure the delivery of safe and effective products to their international customer base.
"In addition, as we prepare to launch our Universal Detach Detect Infusion Sets in the US, Canada, Europe, Mexico and the BRIC countries of Brazil, Russia, India and China – commencing in 2011 we believe these certifications will help to simplify and, in some cases, potentially shorten this key product’s regulatory pathway in those markets," Argaman said.