Meet UL at MedicalDeviceSummit Conference: “EU Unannounced Audits and the MDSAP” on October 15-16 in Washington, DC where UL will be Exhibiting at Booth 221.
Global requirements and procedures for medical device industry audits are changing. One particularly significant change is the new EU requirement for regular unannounced audits of manufacturers and critical suppliers in addition to currently mandated compliance audits. “Unannounced” truly means that companies must grant unrestricted access to notified body auditors without prior notice. This will necessitate significant changes in company procedures, preparedness training, and contractual agreements and communication with key suppliers and with notified bodies.
We look forward to seeing you there!