Quality management is an integral factor in the development, approval, and commercialization of medical devices. With the American Medical Device Summit approaching, we took a moment to sit down with one of the summit presenters, Kari Miller, Vice President of Regulatory and Product Management at Pilgrim Quality Solutions, to gather her insights on the challenges and opportunities in quality management and explore some best practices to create a Quality Nirvana. As Vice President of Regulatory and Product Management, Kari Miller is responsible for driving strategic product direction and delivery of industry best practice solutions to Pilgrim’s customer base. Working with customers, industry analysts, and regulators, as well as Pilgrim’s Development, Professional Services, and Support groups, Kari and her team are responsible for translating market and industry trends, along with customer and regulatory requirements, into industry-leading enterprise quality management solutions that meet the needs of the heavily regulated Life Sciences market. Additionally, Kari leads the development of user documentation and solution presentations. Working with Pilgrim’s Customer Product Advisory Board, Kari is responsible for the company’s product roadmap, product partner relationships, and overall product direction.