ComplianceWire® Content Solutions to FDA Observations for Medical Device Companies

The UL Solutions experts at ComplianceWire^® are in the business of mitigating risk by helping support your critical areas with effective training programs. This will help prepare your company to be audit-ready for an FDA or other agency inspection at any time. To support your success, UL Solutions subject matter experts have reviewed the FDA’s audit observations from field audits of medical device companies conducted from 2013 to 2022 and summarized the 18 most cited areas.  

We then mapped our ComplianceWire^® content catalog offerings to these areas of focus from the FDA to produce the resulting document. By implementing these e-learning courses into your training programs annually or more frequently, you can have confidence that you are providing the necessary training requirements in areas where the FDA has focused in the past.