Many companies treat Additive Manufacturing (AM) as a rapid prototyping tool, but in a regulated environment, "good enough" isn't enough. Transitioning to full-scale production requires a rigorous validation strategy that ensures every part is safe, consistent, and audit-ready.
This webinar demystifies the IQ/OQ/PQ framework specifically for the additive workflow. Drawing on real-world insights from Stratasys Direct’s ISO 13485-certified facilities, we’ll show you how to build a foundation for repeatability and regulatory confidence.
Andrew Carter is the Manager of Manufacturing Engineering at Stratasys Direct, where he leads a team of engineers focused on advancing production processes, creating industry specification and scaling high-performance additive manufacturing applications. He is responsible for driving alignment between engineering, fulfillment, maintenance, and quality teams—ensuring efficient, validated, and production-ready AM workflows across Stratasys Direct’s range of technologies, which includes FDM™, PolyJet, SAF®, SLS, P3™ DLP, SLA, and MJF. Andrew’s expertise spans process development, capability analysis, and operational improvement, with a current emphasis on driving process validation and qualification for regulated industries like Medical, Aerospace and Automotive. Andrew was named one of SME’s “30 Under 30: Future Leaders of Manufacturing”, recognizing his early leadership and continued impact on the future of advanced manufacturing. He brings a hands-on, systems-level perspective to industrializing additive technologies and is passionate about enabling the next generation of scalable, high-reliability AM solutions to address global supply chain risk, localized production and re-industrialization of North America. He holds a Master of Science in Mechanical Engineering from the University of Colorado Boulder and a Bachelor of Science from Boston University.
