OverviewAll life science businesses are required to maintain their Quality Management System training (QMS) processes in a state of control, via controlled documents and objective evidence in the form of record keeping requirements. Medical device designers and manufacturers are required to follow ISO 13485 training, and will be expected to implement the 2016 revision changes. They will have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOP training, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records.The webinar will first present the key differences between ISO 13485 2016 versus ISO 13485 2003.Next, the speaker will provide an overview of the updated standard.Why Should You AttendThe changes to this standard will have profound implications to how Quality Management Systems (QMSs) interact internally and between different supply chain agents.It would be a major oversight to think of these changes as anything but a game-changer in terms of expectations and requirements.Rather than wait to be surprised by unexpected requirements, or to implement them haphazardly, it is better to understand what is coming and begin to plan for the changes that will permeate throughout all areas of your organization’s quality processes.This webinar is an overview of the coming changes and their implications.Areas Covered In This WebinarISO 13485 2016 versus ISO 13485 2003Overview of ISO 13485 2016:Systemic RequirementsManagement RequirementsResource RequirementsRealization RequirementsRemedial Requirements Learning ObjectivesChanges to ISO 13485 2016, although allowing more flexibility, introduces significant, comprehensive, and systemic changes involving the following areas:Regulatory requirementsRisk-based approachMedical device fileRecord keepingProduct realizationUser trainingDesign and developmentPurchasingProcess validation guidanceServicingComplaintsDelivery of nonconforming product improvement Who Will BenefitManagers, Supervisors, Directors, and Vice-Presidents in the areas of:R&DManufacturing EngineeringDesign AssuranceQuality AssuranceOperationsDocument ControlLevelIntermediate