Warning Letters lifted. Programs back on the critical path.
Hands-on quality, program, and engineering leadership for medical device and IVD companies — QMSR and ISO 13485, ISO 14971 risk management, 483 and Warning Letter remediation, and launch.
Warning Letter Lifted
Global IVD company, multi-site remediation
1,000+ Risk Documents
Created and approved under ISO 14971
20+ Risk Specialists Certified
A program that runs after I leave
60 Plans —> 1
Consolidated Risk Management Plans across 60 products
“MEDEVEX consistently and gracefully carried out this 2-year program with a calm, steady, systematic, and empathetic demeanor.”
“Aaron is a hardworking, strategic, and highly effective leader who consistently delivers results.”
Aaron Vant
MBA · PMP
Lean Six Sigma Black Belt
Mission
For decades I've led quality systems, program management, and design and manufacturing engineering for medical device and IVD companies — startups to global manufacturers. I translate evolving regulations into practical, competitively compliant systems, and build the capability to keep them running after I leave. When a team is behind, under-resourced, or heading into an inspection, that's where I do my best work.
DELIVERED
Behind schedule, under-resourced, or heading into an inspection?
Email aaron.vant@medevexconsulting.com or call 952.356.7364.
I reply within one business day.
Project / Program / Portfolio Management (PMO)
I build engaged, accountable, high performing teams by facilitating:
Scope Determination and Priorities Alignment across the team and stakeholders
Visual Management Scheduling with Milestones and Critical Path
Business Case and Budget plan creation and expense management
Resource Management with Coaching and Mentoring to Optimize Performance
Progress Reporting and Stakeholder Communication
I run programs on agile, lean, continuous-improvement principles and hard critical thinking - so the right problems get solved the first time and the hidden factory is eliminated. I keep communication high and risks managed proactively, with tactical countermeasures the moment a program needs them, so the teams I support succeed.
Is your device program actually on track?
Find the hidden factory before it eats your timeline.
Take the free 5-minute Program Readiness Check used by device teams to catch the rework, misalignment, and critical-path gaps that quietly blow schedules and budgets. Includes:
a 7-section check across scope, schedule, risk, team, and waste.
a scoring guide to see where your program is leaking time.
the moves that put a program back on the critical path.
Run your programs the MEDEVEX way. Explore the Program Leadership Playbook, toolkits, and governance packs in our Digital Products, or see how we work together on Work with MEDEVEX.
Quality Management Systems (QMS)
Quality is at the center of everything I do. I run gap assessments and build Quality Plans that integrate and improve your Standard Operating Procedures (SOPs) and templates for competitive compliance with evolving regulations and standards - and I guide the implementation so the plan actually closes on time.
Quality Management Systems per ISO 13485:2016
Design Controls per 21 CFR 820.30
Risk Management per ISO 14971:2019
Design Change per 21 CFR 820.40
Production and Process Controls per 21 CFR 820.70
Nonconformance per 21 CFR 820.90
Complaint Handling per 21 CFR 820.196
Corrective and Preventive Actions (CAPA) per 21 CFR 820.100
Field Action / Recalls per 21 CFR 806
Are you ready for the FDA’s new QMSR?
Find your compliance gaps before an auditor does.
The QMSR is now in effect and builds ISO 13485 into 21 CFR Part 820. Take the free 5-minute self-assessment used by medical device and IVD teams to spot the gaps most likely to surface in an inspection. Includes:
an 8-section readiness checklist across your full quality system.
a simple scoring guide to prioritize your gaps by risk.
the exact areas inspectors probe first - and how to get ahead of them.
From a single SOP to a complete QMS-in-a-Box — browse the Quality digital products, or ask about a gap assessment on Work with MEDEVEX.
Development and Manufacturing Engineering
My technical work runs from ideation through launch and into post-market monitoring and sustainment:
Understanding customer needs and translation into design input requirements
Optimizing design outputs, including labeling, with less costly iteration cycles
Planning and Executing risk based Verification & Validation testing
Establishment of Device Master Records, Batch Records, Procedures and Forms
Creating comprehensive Design History Files with complete traceability
My engineering ethos is rapid learning and never settling for the status quo - optimizing Safety, Quality, Delivery, Cost, and Productivity in everything I build. I run a disciplined stage-gate approach with key stakeholders, and my design reviews are clear enough for auditors and future teams to follow. I've taken products from concept through clearance and launch without disrupting supply.
Will a late design change blow your budget?
Catch the costly design gaps before tooling is cut.
Take the free 5-minute Design and Manufacturing Readiness Check - from customer needs to launch - used to catch the manufacturability and traceability gaps that get expensive after validation. Includes:
a 6-section check from design inputs to post-market.
a scoring guide to gauge your late-change risk.
where to engineer manufacturability in from the start.
Engineer manufacturability in from the first review — see the Design Controls and Design Transfer digital products, or book a Design & Manufacturing Readiness Review on Work with MEDEVEX.