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Quality teams often think of their role as different and separate from product development. However, in today’s increasingly complex medical device market, a product-centric approach to quality management is fundamental to delivering high-quality devices. Next-level proactive quality management processes require a closer connection between product development and quality teams to address...
Why the need to validate? In the journey to deliver safe and effective devices to market, medical device manufacturers must simultaneously manage a myriad of regulations. To maintain quality compliance throughout the manufacturing process, quality leaders have the option to use various types of quality management systems (QMS). They can leverage manual, paper-based ones; on-premises software; or...
Introduction FDA inspections are an unavoidable and often unwelcome reality for medical device manufacturers, and knowing how to prepare for them effectively and confidently is vital to success. Not having a proper plan in place can have dire consequences for organizations. Quality failures can result in everything from warning letters to major compliance actions requiring facility shutdowns,...