Ensuring QMS Preparedness in Light of the MDR & IVDR with a Focus on Economic Operator Compliance, Enhanced Supplier Control & Optimal Design of a Robust PMS Strategy, Successfully Managing International Audit Readiness, all while Digitalizing QMS Processes & Data
With the impact of the new regulatory framework in Europe and tight timeframes for compliance, device and diagnostic quality executives continue to focus efforts on updating QMS processes to reflect new and enhanced provisions, all while ensuring ongoing operations are not disrupted. One of the most prominent challenges lies in the reorganization of end-to-end supply chain operations with the new definition of Economic Operators and incumbent responsibilities for which supplier partners, distributors and importers in particular must be efficiently and swiftly trained. In addition, supplier control is at the forefront of both industries’ concern to ensure visibility into partners’ quality systems and ultimately guarantee end-product compliance, as well as long-lasting business relationships. Post-market surveillance and vigilance strategies are also heavily focused on at this time, as ongoing MDD certificates must comply with MDR requirements by May 2020 to remain on the market. Further, with the necessity to collect and manage increasing volumes of data coming from various sources, forward-thinking professionals are analyzing opportunities in digitization technology applicable to quality management systems.
While IVD manufacturers and laboratories benefit from a longer transition time, the countdown has also started for new strategy design and updating of existing QMS. Many test developers are challenged with establishing quality processes from the ground-up, and learning lessons from the medical device industry’s more mature experience offers numerous opportunities to manage costs during the transition. In both industries alike, gaining practical insight into continuous audit readiness programs in light of European as well as international rules including MDSAP is of high interest, to secure positive outcomes all while managing ongoing operations. The 4th edition of the Q1 EU Medical Device & Diagnostic Quality Management Conference will once more enable strategy and solution exchanges through interactive session formats, as well as showcase practical examples from peers’ experience in overcoming timely challenges, in addition to addressing perspectives from Notified Bodies and auditors.