Holistic, Risk-Based Approaches to Supplier Qualification, Monitoring & Performance Evaluation to Meet Regulatory Standards including ISO 13485:2016 and the Medical Device Single Audit Program, Ensuring Global Compliance & Highest Quality Products
As regulations surrounding supplier management and oversight continue to increase, medical device supplier quality executives must consider innovative, risk-based tactics that ensure appropriate levels of monitoring, oversight and control of not only traditional component suppliers but also sub-tier supplier partners. Regulatory changes including the ISO 13485:2016 revisions as well as the comprehensive Medical Device Single Audit Program (MDSAP) now in effect are also increasing the focus on risk management across the lifecycle of supplier relationships, from the earliest stages of selection and qualification. Development of robust supplier management practices will ultimately ensure alignment with international regulations as well as increase the overall quality and safety of medical products utilized throughout the health spectrum creating value for patients, health professionals and medical device manufacturers.
The 2018 editions of the highly anticipated Q1 Medical Device Supplier Quality Assurance Conference will continue to provide the highest level of educational engagement and networking collaboration for medical device executives, with an increased focus on risk management in line with regulatory and internal expectations. Communicating risks across the lifecycle of supplier relationships and translating risks into financial impact will provide insight for not only supplier quality executives, but quality assurance teams responsible for finished product quality. Balancing cost-containment with supplier selection, management and oversight, all within a risk-mitigation framework will ensure corporations implement tactics that measure and maintain the quality of component parts.
Eric Jahnke | Sr. Marketing Manager | Q1 Productions
312.955.0424 | firstname.lastname@example.org