VisionScope Technologies announces receipt of CE Mark for Europe and ISO-13485 Quality System Certification

Nov 25, 2010

Concord, MA November 25, 2010 – VisionScope Technologies, LLC, a medical device company focused on offering less invasive diagnostic imaging solutions to orthopedic surgeons, today announced they have received CE Mark Certification to freely sell and distribute the VisionScope System with Sterile Procedure Kits in the European Economic Area (EEA). The company has previously received FDA 510(k) clearance to market in the U.S.

Additionally, the company has received certification that its Quality Management System is in compliance with EN ISO 13485:2003+AC:2007 as well as Canadian CMDCAS ISO 13485:2003, for the design, development, manufacturing and distribution of its Endoscopic Imaging System and Sterile Accessories. TUV Rhineland is the auditor and Notified Body.

Lim Cheung, Ph.D., General Manager and CTO of VisionScope Technologies, said, "We are pleased that our quality management practice is now recognized to comply with the highest international quality standards. We are committed to providing the highest quality medical devices to benefit patients, surgeons and healthcare payers alike."

The VisionScope System is now available in North America and Europe.