A large healthcare product division with global market presence faced Food and Drug Administration (FDA) compliance challenges triggered by a significant number of medical device reports and product quality issues. The client’s development and delivery platform required a comprehensive, global approach. It needed to include both the development of measurement baselines and a long-term solution. Affinity worked closely with leaders at all levels to complete a prospective and retrospective remediation program. The program included the development of a product quality qualification and management plan, a risk measurement and management process, validation and testing templates, and a defined validation process.
Our work created a long-term solution and identified all high-priority actions The majority of the actions were resolved within 90 days. The business impact is expected to be more than $25M in net savings.