Lately, GP lens manufacturing labs have come under regulatory scrutiny with regard to adherence to 510(k) approved lens design parameters. It goes without saying we all observe the regulations. Just remember, when reporting your marketed designs to regulatory...
What is a quality system?If you’re manufacturing contact lenses, you have already been required by a regulatory agency to establish and follow a quality system. These systems ensure that manufacturers (and finishing labs) continue to meet all of the applicable...