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HeartStitch, Inc. Passes European Regulatory Audit of Its Manufacturing Systems for 2016
FOUNTAIN VALLEY, CA --(Marketwired - March 16, 2016) - HeartStitch®, Inc. today announced that it has received recertification of its EC certification and its ISO13485 after a successful audit by its European notified body. This successful audit certifies HeartStitch® to manufacture and sell its NobleStitch™ EL PFO Closure and cardiac suture products throughout the European Union.
Prof. Anthony Nobles, CEO of HeartStitch®, commented, "Our record in the European Union for Regulatory Affairs and Quality Assurance remains exceptional and our commitment to safety and efficacy reflects this. These successful audits and recertifications demonstrate the internal standards set by our committed team of manufacturing and quality staff."
Ben Brosch, President of HeartStitch®, commented, "Europe remains our largest market and these certifications make it possible for us to continue to supply our NobleStitch™ products to the doctors, hospitals and patients that need these treatments. We are very proud of the level of quality and safety that they represent."
Rich Babcock, Director of HeartStitch®, commented, "We recently hired Faye Dunn, Director of Regulatory Affairs and Quality Assurance, who joined HeartStitch® just prior to the audit and immediately provided the same high level of standard that we require in HeartStitch®. Her contribution has already added to the strength of our systems."
Edith Ramos, Quality Manager of HeartStitch®, added, "It was a large task to add the NobleStitch™ EL to the system merely two months before a major CE audit. The team worked all the necessary hours to be ready, while maintaining the high standard that Prof. Nobles holds us to. We are all dedicated to keeping the high level of quality for our products."
HeartStitch® Inc. was founded by Prof. Anthony Nobles with the intent of leveraging its technologies in the structural heart marketplace. HeartStitch® is focused on the innovative suture-based systems for remotely providing suture repair of structural heart defects and other vascular structures.
HeartStitch® manufactures and markets the NobleStitch™ EL under an exclusive license from Nobles Medical Technologies II, Inc. The NobleStitch™ EL is FDA cleared for vascular suturing in the United States and CE Marked for cardio-vascular suturing and PFO closure in the European Union.
HeartStitch® is a registered trademark of HeartStitch®, Inc.
NobleStitch™ EL for PFO closure
Covered by or for use under U.S. and international patents including one or more of U.S. Patent Nos. 5860990, 6117144, 6245079, 6551331, 6562052, 6733509, 7004952, 7090686, 7803167, 8197497, 8197510, 8246636, 8348962, 8372089, 8469975, 8496676, 8709020, and 9131938.
For more on HeartStitch® visit www.HeartStitch.com
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