New Wave Surgical Receives ISO 13485 and CE Certifications
Certifications Demonstrate New Wave Surgical’s Dedication to Quality
CORAL SPRINGS, Fla. – July 12, 2010 – New Wave Surgical Corp., the developer of the innovative Advanced Laparoscopic Care Kit with D-H.E.L.P. to help medical professionals easily defog and clean laparoscopic and endoscopic medical equipment, announced today that it has received its ISO 13485 and CE certification.
“We are excited to have received this important certification of our production facilities,” said Prudy Gomez, VP of manufacturing of New Wave Surgical Corp. “It is a true testament to the rigorous standards we have in place to ensure quality.”
ISO 13485 is a very stringent medical device quality standard that requires manufacturers to uphold strict quality procedures and redundant quality processes to assure the highest quality in medical manufacturing.
“The entire process was very detailed,” Prudy Gomez said. “We pledge to uphold these standards and produce our devices to the highest quality for doctors and patients all over the world.”
New Wave Surgical has created a patented Advanced Laparoscopic Care Kit with D-H.E.L.P. that allows surgeons to easily clean and defog laparoscopic and endoscopic devices. It also easily allows a surgeon to “white balance” the cleaned device to ensure proper color images during patient surgery.
For more information about New Wave Surgical and its ISO 13485 and CE certifications, please check out its website at www.newwavesurgical.com.
About New Wave Surgical Corp
New Wave Surgical Corp. is a medical device visualization company incorporated in 2006 to design, patent, and market medical devices for the laparoscopic and endoscopic surgical markets. The development of New Wave Surgical’s™ devices was accomplished with the participation of leading surgeons, surgical residents, and operating room staff. New Wave Surgical’s™ medical devices are sterile intra-procedure disposable units that all complement each other to provide a complete visualization improvement solution for the entire endoscopic market.
Media Contact:
Alexander Gomez
New Wave Surgical Corp.
Phone: 866-346-8883




