Our Services
What We Offer
Whatever you're building, we're here to help you take the first step with confidence.
Explore our range of services designed to help you move forward with confidence, wherever you're headed next.
Every engagement starts with a short scoping call to determine whether fixed-fee, retainer, or partnership services are the right fit.
Fixed Fee Services
A fixed, written scope so you know the outcome and the number before we begin.
Fixed fees, clear deliverables, defined timelines. No open-ended hourly meters.
Design & Manufacturing Readiness Review
$7,500.00
Catch the costly design and manufacturability gaps before tooling and validation lock them in.
What’s included:
A review of design inputs and outputs, design-for-manufacturability, and labeling.
A risk-based Verification & Validation plan with defensible sample sizes.
Design transfer and Design History File traceability checked end to end.
Prioritized findings and a practical get-well plan.
Ideal for: Teams heading into a new product launch, a redesign, or a design transfer.
Format: 2–4 weeks · fixed fee
Rapid Competitive Compliance Gap Assessment
$8,000.00
Quickly know where your quality system stands against the QMSR and ISO 13485 and what to fix first.
What’s included:
A structured gap assessment across your QMS: design controls, risk management, CAPA, complaints, supplier controls, and post-market.
Findings ranked by risk and clinical consequence - the highest-impact gaps surfaced first.
A prioritized Quality Plan with owners and a realistic timeline.
A working session to walk you and your team through the results.
Ideal for: Device and IVD teams facing the QMSR transition, prepping for an audit, or unsure where they stand.
Format: 2 weeks · fixed fee
483 / Warning Letter Readiness & Remediation Assessment
$12,000.00
See what an inspector will see (before they do) and get a ranked plan to close it.
What’s included:
A conformance review / mock inspection against ISO 13485, ISO 14971, and 21 CFR 820 / QMSR.
A 483 crosswalk mapping findings to observations, with patient-safety issues elevated.
Remediation sequenced by clinical consequence, plus an inspection-readiness plan.
Optional hands-on remediation support to close the findings.
Ideal for: Companies with an open 483 or Warning Letter or who want to make sure they never receive one.
Format: Assessment 2–4 weeks · (remediation scoped per situation · remediation quoted on scope separately)
ISO 14971 Risk Management File Build (per product or site)
$15,000.00
Risk files that drive decisions and survive an audit - not binder filler.
What’s included:
Risk management plan(s), FMEAs (use, design, process), and product safety references.
System-level risk assessments, benefit-risk analysis, and risk management reports.
A single plan across a product family - not sixty repetitive plans.
Training and handoff so the program is self-sustaining after we leave.
Ideal for: Teams with gaps in their ISO 14971 files, or building risk management under remediation pressure.
Format: 4–12 weeks · fixed fee or milestone-based
Comprehensive, Multi-Process Compliance Gap Assessment
$18,000.00
Know exactly where your quality system stands against the QMSR and ISO 13485 and what to fix first.
What’s included:
A structured gap assessment across your QMS: design controls, risk management, CAPA, complaints, supplier controls, and post-market.
Findings ranked by risk and clinical consequence - the highest-impact gaps surfaced first.
A prioritized Quality Plan with owners and a realistic timeline.
A working session to walk you and your team through the results.
Ideal for: Device and IVD teams facing the QMSR transition, prepping for an audit, or unsure where they stand.
Format: 4 weeks · fixed fee
Other ways to engage
Fractional Leadership & Quality-on-Call
Most medical device and IVD teams hit a point where they need a seasoned Quality or Program leader - but not a full-time one, and not a six-figure salary.
A MEDEVEX retainer gives you that senior partner on a predictable monthly basis: a named leader accountable for keeping your program on the critical path and your quality system audit-ready, month after month.
Quality-on-Call
A senior sounding board on tap for the questions and reviews that shouldn’t wait.
Best for: Early-stage startups and lean teams that need expert judgment occasionally, not a standing role.
What’s included:
A set block of advisory hours each month
(calls, document review, quick guidance).Priority email and scheduling access.
A monthly check-in to keep issues from piling up.
Roll-over of a limited number of unused hours.
Cadence: Approximately 8 hours / month
Investment: from $2,500 / month
Fractional Leadership
A part-time program or quality leader who actively steers the work.
Best for: Teams running a real program or standing up a quality system who need consistent senior leadership.
What’s included:
Standing weekly cadence and attendance at key program or quality meetings.
Ownership of the plan: scope alignment, critical path, risk register, and follow-through.
Quality-system stewardship: gap tracking, CAPA and audit readiness, documentation oversight.
Coaching and mentoring of your internal team.
Monthly progress and risk reporting to leadership.
Cadence: Approximately 2 days / week equivalent
Investment: from $8,000 to $10,000 / month
Embedded Program / Quality Lead
Near-full-time senior leadership through a launch or a remediation.
Best for: Companies in active launch, design transfer, or 483 / Warning Letter remediation that need hands-on leadership now.
What’s included:
Everything in Fractional Leadership, at higher intensity and availability.
Day-to-day leadership of the program or remediation, driving deliverables to closure.
Direct management of cross-functional workstreams and external partners.
Inspection-readiness and stakeholder communication.
A defined exit that leaves the capability self-sustaining.
Cadence: Approximately 3 days / week equivalent
Investment: from $12,000 to $18,000 / month
What a retainer includes
Direct access to Aaron Vant (MBA, PMP, LSSBB). Not a handoff to a junior associate.
A named leader accountable for outcomes, with continuity month to month.
A written scope and success measures, reviewed each quarter.
Predictable monthly billing. No surprise invoices.
How it works
Minimum initial commitment of 3 months, then continues month-to-month; 30 days’ notice to end.
Scope and hours are agreed up front and revisited quarterly as needs change.
Unused hours roll over up to a stated cap; sustained overages convert to the next tier.
Start with a short fit call and a two-week onboarding to get up to speed fast.
Is a retainer right for you?
A retainer is a good fit if you have an ongoing need - a program to steer, a quality system to keep audit-ready, or a remediation to lead.
A retainer is not the right fit if you need a one-time, defined deliverable. For that, a fixed-scope package is faster and cheaper - see above.
Want to explore a retainer? Do not hesitate to reach out to aaron.vant@medevexconsulting.com.
Partner with MEDEVEX
Ideal Partners
We work well with:
eQMS and MedTech software vendors
Testing labs and CROs
Regulatory affairs and clinical firms
Contract manufacturers and design houses
Fractional-executive and consulting networks
MEDEVEX partners with the software vendors, labs, and firms that serve medical device and IVD companies. When your clients need help with quality systems, risk management, program leadership, or design and manufacturing engineering, we’re a specialist you can refer with confidence - and we return the favor.
Ways to work together
Referrals, both directions - we cover the quality, program, and engineering work you don’t cover; we send you the software, testing, and services we don’t.
Co-marketing - joint webinars, articles, and checklists for a shared audience.
White-label / subcontracting. MEDEVEX delivers as your bench or under your brand.
Implementation partner. MEDEVEX stands up and operationalizes your platform for device clients.
Who to refer to MEDEVEX
Device and IVD companies facing a QMSR or ISO 13485 gap, a 483 or Warning Letter, an ISO 14971 risk build, a stalled program, or a product launch or design transfer. If a client is behind, under-resourced, or heading into an inspection, that’s our sweet spot.