The challenges of medical manufacturing, from evolving quality systems requirements to determining whether to outsource a technology or keep it in house, will be explored at free conference sessions during the upcoming Advanced Design & Manufacturing (ADM) Expo in Cleveland, OH. The trade show and conference comes to the Huntington Convention Center of Cleveland on March 7 and 8.
A panel discussion on March 7 will dive into ISO 13485 certification, including the latest version of the international standard for medical device quality management systems. ISO 13485:2016 introduces a number of revisions that medical device manufacturers and their critical suppliers must implement if they are to achieve compliance by the March 1, 2019, deadline. First and foremost is a broadening of risk management principles to include all aspects of a quality management system. The panel also will discuss the benefits of ISO 13485 certification in terms of access to global markets and how certification can help meet regulatory requirements and customer expectations. Consultant Laura Green will moderate the conversation and panelists include Dominick Villani, Vice President of QA/RA at Enable Injections; Christopher Basil, Technical Program Manager for ISO 13485 at Smithers Quality Assessments; and Ken DiFranco of Manufactured Assemblies Corp.
Also on March 7, Jeff Ellis, Principal Research Scientist at Battelle, will discuss how to reduce risk and avoid product recalls through the appropriate use of materials science.
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