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.
Environmental Policy
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.