LUMENDI ACHIEVES ISO 13485 CERTIFICATION FOR ITS MEDICAL DEVICES
WESTPORT, CONNECTICUT, August 1, 2017 – Connecticut-based Lumendi, LLC (www.lumendi.com) recently received ISO 13485 certification from BSI, a worldwide recognized leader for medical device testing and certification. Implementing and maintaining ISO 13485 certification is required for distributing medical devices in many international markets.
“Providing medical devices that consistently meet or exceed expectations is important to patient outcomes so our Quality Management System, which complies with ISO 13485, will help ensure our customers are pleased with our products and services,” said Dennis Daniels, Lumendi’s Senior Director of Quality Assurance and Regulatory Affairs.
ISO 13485 Certification is an international harmonized standard published by International Organization for Standardization (ISO), is applicable to medical device manufacturers and specifies the framework required to create and maintain Quality Management Systems. Certification to ISO 13485 indicates that Lumendi has the management structure and systems in place to ensure that its medical devices are designed, manufactured and distributed with patient safety, product performance and quality as the highest priority.
“Customer satisfaction in all aspects of Lumendi’s business is our primary objective and getting certified to ISO 13485 was an important company objective for 2017,” commented Michael Parrilla, COO of Lumendi, LLC. “Lumendi recently began distribution of the DiLumen™ Endolumenal Interventional Platform in the U.S. Another important milestone for Lumendi will be to launch the international distribution in Europe by the end of this year,” he added.
Lumendi received U.S. FDA 510(k) clearance to market the DiLumen™ in December 2016. The DiLumen™ EIP is indicated to ensure complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis and endoscopic treatment. Because such a device may improve endolumenal treatments, DiLumen™ EIP may better enable these less invasive procedures and take the place of open or laparoscopic surgery, thereby preserving anatomy, shortening recovery and reducing healthcare costs. A post-market outcome study is now underway to demonstrate the capabilities of DiLumen™ during endoscopy procedures.
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