QSIT Is Ending: How to Achieve Audit Readiness for Medical Devices Under FDA QMSR

The US FDA has retired its QSIT (Quality System Inspection Technique) requirements for medical devices and introduced the Quality Management System Regulation (QMSR). Join this webinar to learn strategies for the shift to Big Q thinking, a broader system-based approach to quality management. 

“Big Q” thinking means that a company must demonstrate a quality system designed to proactively manage and prevent risk across the organization, rather than simply reacting to them. This system must align with the ISO 13485 Risk Standard, ISO 9001 Quality Standard, and all other applicable regulatory requirements. 

Although medical device companies have had two years to prepare for the QMSR transition, uncertainty remains regarding how the FDA will focus on its compliance efforts under these new requirements. Additionally, this shift from an inspection focus to a system focus will require renewed efforts to engage leadership in the quality system. This new direction aims to encourage companies to view quality as an end-to-end system, led by leadership, and fostering a culture of quality. 

Key takeaways:

The speaker will focus on three key learning points on the transition from QSIT to QMSR as provide the participants: 

• A means to explain the implication and impact of the shift from inspection to a system approach to proactively manage quality and risk aligning with ISO 13485 and ISO 9001 standards to their organizations.
• Present tips to enable leadership engagement as the QMSR necessitates increased involvement from leadership in managing the quality system and crucial to building a culture of quality
• Provide a readiness assessment to better prepare for an FDA audit under QMSR.