VisionCare

FDA

VisionCare Devices, Inc. is FDA Registered and has been for over twenty years.    We like to boast about our quality record because we are very proud of our  internal Regulatory Compliance and our Quality accomplishments.  In fact,  VisionCare Devices, Inc. has never had an FDA recall.  In the end, patient safety is what matters and our products are second to none in patient safety!

ISO13485:2003

VisionCare Devices, Inc. is ISO13485:2003 certified.  BSI, Inc. is our notified body and routinely inspects our facility, records, and quality management system.  We have active and compliant CAPA, complaint, internal audit, and training programs.  Our staff is trained utilizing a combination of classroom style instruction and on the job training.  Key members are given ISO13485:2003 and Internal Auditor training from a notified body or certified training establishment. 

ISO13485:2003

VisionCare Devices, Inc. is committed to improving its footprint upon the planet earth.  All members of management are involved in the execution of the environmental policy and its impact.