The Fall 2021 MatSE 590 for graduate students consists of an exciting and jam-packed schedule. MATSE 590 is a colloquium (1-3 credits) consist of a series of individual lectures by faculty, students, or outside speakers.
Graduate students will receive a weekly email with information via @psu.edu email. Graduate students are required to attend all 590 Seminars. If you have any questions, please email Hayley Barnes at firstname.lastname@example.org.
*Due to the ongoing Covid Pandemic this program is being offered virtually through Zoom. Please reference the weekly email from Hayley Barnes (email@example.com) for Zoom link.
September 16, 2021
“Safety in a Small Company”
Douglas R. Dillon, Director Quality Assurance and Regulatory Affairs, Actuated Medical, Inc.
Small companies have the same obligations for employee safety as large companies, but often lack the dedicated resources and credentialed professionals found in larger companies. Therefore, as with many other business functions in a small company, responsibility for safety oversight is provided by an employee or group of employees for whom this is not their primary function, such as R&D, Quality, and Manufacturing. This presentation will review Actuated Medical’s approach and compare and contrast this approach to that taken by other companies in which the presenter has participated in the safety program.
Doug is responsible for managing AMI's ISO–certified quality management system (QMS). He ensures design and manufacturing compliance to ISO 13485, ISO 14971, 21 CFR 820, Medical Devices Directive 93/42/EEC, and the Medical Devices Single Audit Program (MDSAP) with a focus on proactive risk management while maintaining innovative development. He also guides best quality system documentation to ensure that design history files, device master records, and other documentation follow the Seven Stages of Development that will enable ease of transition into acquirers’ QMS. He is also responsible for submissions to regulatory bodies, including the U.S. Food and Drug Administration (FDA), Canada Health, and the European Union (EU), with the goal of ensuring efficient and cost-effective design and development activities and timely regulatory approvals through early and frequent collaboration with regulatory bodies. His prior experience includes R&D in the life sciences, quality system and regulatory project management, and regulatory experience in pharmaceuticals, biologics, and medical devices. Doug earned his M.S. in Polymer Science from Drexel University.