2027 Quality Readiness Summit: The Rules Changed In 2026, Is Your Quality System Ready?

QMSR is in effect, and FDA has replaced QSIT with a new risk-based inspection program, CP 7382.850. For teams planning a release, submission, inspection, or customer review in 2027, the question is immediate: can your team show what changed, whether it affected risk, what evidence supports the decision, who approved it, and what happens next, without piecing the story back together across teams and systems? This summit connects the current inspection approach to the day-to-day work of keeping product changes, evidence, and quality decisions connected as devices evolve.

Why this, why now
You're planning 2027 right now. The scrutiny your quality system will face next year was largely set by four changes that already landed in 2026, and most teams haven't fully absorbed them:

• The FDA inspection model is new. On February 2, 2026, the FDA retired QSIT, the checklist method it used for a quarter century, and replaced it with a risk-based program (CP 7382.850). Inspectors now follow your risk documentation as the roadmap, and internal audits, supplier audits, and management reviews are no longer off-limits. Your 2027 inspections run on this model, not the old one.

• The FDA itself is operating differently after significant staffing reductions, which has changed how and when scrutiny shows up, and there's no sign that reverses next year. The agency has built out internal AI tools and is piloting single-day inspections using AI to identify low-risk facilities. Cuts combined with modernization may add new twists to the inspection schedule.

• The question of AI governance can't be avoided. Customers, notified bodies, and procurement teams are asking how teams govern their AI. Expect that in more contracts and qualifications in 2027, not fewer.

• Scale and diligence bring their own reviews. QMSR transitions, an acquirer's diligence, a major customer's vendor qualification: each tests your quality system on someone else's clock, and that pressure grows as you grow.