Are your labels compliant? SOPs updated? Information submitted to GUDID correct? These are just the basic requirements for UDI compliance. There is so much more to UDI compliance.
Direct mark? Barcode verification? Point of use? Refurbished devices? Standalone software? Different packaging levels? Systems validated? Quality agreements? And much more. Systems and processes never thought to be impacted by UDI can, in the right situation, require inclusion in your UDI program.
RSQM has the experience to assess your UDI program and make recommendations on improvements that may be needed. We have done more than 25 UDI program implementations and assessments with clients in the US and OUS.
Our assessment program will review all aspects of your UDI implementation process including product labels, GUDID submissions, SOPs, processes, systems and more.
Don't let a FDA audit discover problems with your UDI program. Contact RSQM today!
Direct mark? Barcode verification? Point of use? Refurbished devices? Standalone software? Different packaging levels? Systems validated? Quality agreements? And much more. Systems and processes never thought to be impacted by UDI can, in the right situation, require inclusion in your UDI program.
RSQM has the experience to assess your UDI program and make recommendations on improvements that may be needed. We have done more than 25 UDI program implementations and assessments with clients in the US and OUS.
Our assessment program will review all aspects of your UDI implementation process including product labels, GUDID submissions, SOPs, processes, systems and more.
Don't let a FDA audit discover problems with your UDI program. Contact RSQM today!