Regulatory operations

When the US Food and Drug Administration’s (FDA) new Quality Management System Regulation (QMSR) comes into force in early 2026, medical device manufacturers run the risk of falling down if they failed to start the process of updating standard operating procedures (SOPs) for quality systems right now, industry experts advise.

Reviewing and updating standard operating procedures (SOPs) for quality systems should be top of mind for medical device manufacturers so they’re in compliance with the US Food and Drug Administration’s (FDA) new Quality Management System Regulation (QMSR) when it takes effect in early 2026.

Achieving regulatory excellence involves...

Regulatory Excellence is a crucial aspect of the Medical Technology industry, which involves complying with strict guidelines, ensuring procedural accuracy, and aligning strategically to navigate the complex landscape of compliance and approvals.

Regulatory Excellence encompasses the adherence to stringent guidelines, procedural accuracy, and strategic alignment necessary for navigating the complex landscape of compliance and approvals within the MedTech industry.

Regulation vs. Innovation in the medical devices industry represent an essential and never-ending balancing act and dance that must play out. In this roundtable webinar, four longtime MedTech industry experts will dissect and discuss challenges manufacturers face as they work to comply with rules and regulations.

Why regulatory operations decide time-to-market — where manual submission assembly introduces errors, and what the FDA's refuse-to-accept rate reveals about them.