This is a major headache. How can companies make that determination? How can they trigger such an analysis over the major change or the series of smaller changes. What approaches are required for product changes; for process changes. How is the process risk-based? How to maximize the process against scarce resources. What are the different considerations for CE-marked product?
Areas Covered in the Session:
U.S. FDA device clearance / approval
FDA's and EU's emphasis
Product changes and filing a new 510(k) - who's responsible
Tracking and evaluating changes - the 'tipping point'
Is the process 'risk based'?
K-97-1 and the FDA's 'Decision Tree'
Documenting the process / rationale
Resolving a 'wrong decision
- Senior management, project leaders, internal / external consultants
- Regulatory affairs
- Quality systems personnel / QAE
- R&D and engineering staff
- Personnel involved in Lean and Six Sigma Initiatives
- New product development, regulatory submissions, driving company-wide quality initiatives, under a risk-justified approach
- CAPA personnel desiring to minimize post-production / life cycle, root cause investigation, and other costly problems.