Maintaining Audit Readiness with Limited Internal Quality Resources

Описание: Maintaining audit readiness is one of the hardest challenges for post-market medical device teams—especially when quality resources are limited and team members wear multiple hats.

In this on-demand webinar, Molly Lane (Audit Manager, Rook Quality Systems) and Jan Creidenberg (CEO, Invisian Medical) share real-world insights on how lean MedTech teams stay audit-ready without overbuilding their quality organization.

This discussion focuses on practical execution, not theory. You’ll hear firsthand lessons from a post-market Class II manufacturer that has successfully navigated FDA inspections, supplier oversight, and QMS growth with a small internal team and fractional support.

In this webinar, we cover:

• What actually breaks first when quality teams are stretched thin
• How to maintain continuous audit readiness instead of reactive prep
• Common audit gaps in post-market organizations
• Managing independence and oversight with limited headcount
• Lessons learned from a real FDA inspection experience
• When external or fractional quality support becomes necessary

Whether you’re preparing for your first FDA inspection or trying to maintain compliance after commercialization, this session offers practical guidance you can apply immediately.

🔗 Learn more about Rook Quality Systems: https://rookqs.com
📩 Questions or follow-up: [email protected]