Are We on the Right Track? – 7 SDLC Process Questions for Medical Device Teams

How to determine whether you’re headed for Glory or FDA Recall

  1. Do Regression activities negatively impact your Time-to-Market?
  2. Are you prepared for a Surprise Audit?
  3. Are your Process Improvement activities – Proactive or Reactive?
  4. What are your Five most effective Cost of Quality Metrics?
  5. Does Design Output start before Design Input is Approved?
  6. Are your CAPA Effectiveness Checks…Effective?
  7. Are Risk Mitigations “Traced” & “Verified”…?

Want to confirm you’re on the right track by capturing measurable feedback?

Call & schedule a Free Process Assessment – today!