News

February 07, 2011

Spring-Set Health Solutions Ltd., Achieves ISO 13485:2003 and ISO 9001:2008 Certifications

TIRAT CARMEL, ISRAEL--(Marketwire - Feb. 7, 2011) - D. Medical Industries Ltd. (NASDAQ:DMED)(TASE:DMDC) ("D. Medical" or the "Company"), a medical device company engaged through its subsidiaries in the research, development, manufacture and sale of innovative products for diabetes treatment and drug delivery, announced today that its subsidiary, Spring-Set Health Solutions Ltd. (formerly "Medx- Set Ltd."), has achieved ISO 13485:2003 and ISO 9001:2008 certifications. Spring-Set designs and markets the Company's Universal Detach Detect Infusion Sets.

ISO 13485:2003 is an internationally recognized standard developed to ensure that companies provide medical devices that consistently meet regulatory requirements. 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 is an internationally recognized quality management standard. The standard 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.

"The achievement of both ISO 13485:2003 and ISO 9001:2008 certifications demonstrates our continued commitment to the highest levels of quality management and design controls to ensure the delivery of safe and effective products to our international customer base. In addition, as we prepare to launch our Universal Detach Detect Infusion Sets in the United States, 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," said Efri Argaman, D. Medical's Chief Executive Officer.

Back