DALLAS, Dec. 16, 2019 /PRNewswire/ — As of November 28th, 2019 Eclipse achieved Medical Device Single Auditor Program (MDSAP) certification, which is based on ISO 13485:2016 and satisfies the requirements of US FDA, Health Canada, Brazil (ANVISA), Japan (MHLW and PMDA) and Australia (Therapeutic Goods Administration). MDSAP certification is mandatory in Canada and other countries are expected to follow.
Eclipse is extremely proud to have achieved this certification and looks forward to continuing to provide superior products to its customers in the US and abroad.
Eclipse Founder and CEO Tom O’Brien wants to thank the quality department for putting in the hard work to make this certification possible. “This certification continues to validate that Eclipse is at the pinnacle of industry standards and regulation,” O’Brien says.
For more than 25 years, Eclipse has been an innovative leader in advancing medical technologies to bring medical supplies to practices in the U.S. and around the globe. Based in Dallas, Eclipse manufactures and distributes high-efficacy, affordable products to physicians that exceed patient expectations and put immediate profit into our partners’ practices.