Get Better Medical
Devices to Patients Faster.
The Voluntary Improvement Program (VIP) accelerates a culture of quality. Participants recieve 2x faster FDA reviews of their Premarket Approval (PMA) submissions.
Trusted by regulators and industry leaders
Proven Business Results
VIP is a structured approach to dramatically improve business objectives.
Case Study Results Include:
882
More Lives Saved
Increase in patient access to life-saving treatment.
65%
Production Increase
Boost in daily manufacturing production.
$286K
Annual Savings
Direct savings through improved efficiency.
70%
Lower Turnover
Decrease in staff turnover rates.
The FDA Advantage
VIP adopters benefit from specific regulatory opportunities to accelerate device quality and manufacturing improvements as noted in official FDA guidance.
Optimized Inspections
Surveillance inspections waived during first 2 years of enrollment, risk-based thereafter.
Accelerated PMA Submissions
Streamlined process for 30-day change notices, new PMAs, and site transfers.
Transformed FDA Relationship
Direct line of communication with FDA's VIP staff to enable proactive and collaborative discussions.
Continuous Quality Improvements
"The MDDAP program has enabled Boston Scientific to establish new relationships with peer companies for sharing of best practices, while also strengthening our relationship with FDA."
Ready to Begin Your Journey?
Join the top manufacturers who are improving quality and getting faster approvals. Eligibility requires prior FDA inspection or MDSAP audit.