Scilife CaseLab | What FDA QMSR requires from your QMS and how to get ready

Many companies assume their current systems will hold. But early inspections are already showing gaps, and expectations are becoming more structured and less forgiving.

In this session, we’ll unpack what QMSR really requires in practice, and where companies are most at risk.

CaseLab | What FDA QMSR requires from your QMS and how to get ready

April 23, 2026 | 16:00H (CEST)

We’ll explore:

• Where companies are already falling short under QMSR
• What FDA inspectors are focusing on in early enforcement
• How to close gaps in risk management, documentation, and QMR processes
• How to move from reactive compliance to inspection-ready operations
• How a modern eQMS can support QMSR readiness without increasing operational burden

You’ll hear from Jennifer Mascioli, MedTech expert, Angel Buendía, Scilife’s Knowledge Manager and Santosh Paragond, Account Executive, who will show you how to translate QMSR requirements into sustainable, compliant operations.

Register here for free

Join us to make sure your QMS is ready for what QMSR demands!