MADISON, WI, July 3, 2018
Imbed Biosciences, a developer of advanced biomaterials and soft tissue repair devices, announced today that the company has formally received its ISO 13485:2016 certificate. The new certificate supersedes the existing certification and confirms that the company is compliant with the newest international standard governing the quality manufacture of medical devices. The transition audit was conducted by British Standards Institution (BSI), a UK standards body and global business certification company.
“This transition to the new version of ISO 13485 is a great accomplishment for our team. It allows Imbed’s partners and customers to have the highest level of confidence in the quality of our products. Furthermore, updated ISO certification will help enable us to market our products internationally. This is a key element of our application for CE marking for Microlyte® Matrix, which will be submitted later this quarter” said Jeff Dalsin, Vice President of Product Development and Quality.
About Imbed Biosciences, Inc.
Imbed Biosciences is a privately held medical device company developing next-generation medical devices for the management of burns, chronic ulcers, gastro-intestinal defects, and soft-tissue repair. The company has a portfolio of products in development based on its patented Microlyte® Matrix polymeric multilayer platform that presents bioactive molecules on tissue surfaces to combat local pain and infections, support soft-tissue repair, and reduce antibiotic/opioid abuse. Imbed is backed by venture capital group WISC Partners based in Madison, WI, and has received research grants from the National Institutes of Health and the National Science Foundation.