About MEDEVEX

MEDEVEX Consulting was founded on a simple idea: medical device and IVD companies
deserve a partner who has actually done the hard work — not just advised on it.

I’m Aaron Vant, founder and principal consultant. Over decades in highly regulated industries, I’ve led quality systems, program management, and development and manufacturing engineering for medical device and IVD companies, from early-stage startups to global manufacturers. I’ve stood up risk management programs across multiple sites, guided products from concept through launch without disrupting supply, and led teams out of FDA 483s and Warning Letters under real deadline pressure.

What clients tell me they value most is a calm, systematic approach and the ability to see the big picture while staying deeply engaged in the details. I translate evolving regulations into practical, competitively compliant systems; and most importantly I build the internal capability to keep them running after I leave.

Credentials: MBA · PMP · Lean Six Sigma Black Belt (LSSBB).

If your team is behind, under-resourced, or heading into an inspection, that’s where I do my best work. Let’s talk.

Case Studies

  • Situation:  A multi-million-dollar in-vitro diagnostics company was operating under an FDA Warning Letter, with legacy products lacking the risk infrastructure to support the quality system. The company needed a corporate ISO 14971 risk management program operable across multiple sites and product lines, during a period of extensive remediation.

    What we did:  Built remediated ISO 14971 risk management files across multiple global divisions; created and approved 1,000+ risk documents; and stood up a self-sustaining program by training and certifying 20+ risk management specialists, all during active remediation.

    • Translated ISO 14971 into a multi-site corporate procedure operable across globally manufactured legacy and new product lines.

    • Created brand new risk deliverables (product safety references, system risk assessments, risk management files) and consolidated 60 repetitive risk management plans down to a single plan covering all 60 products; permanently cutting future documentation update and approval burden.

    • Made it self-sustaining: created a new 'Risk Management Specialist' role and curriculum and certification process.

    • Aligned the risk program with the process-validation program and other design-control elements.

    • Delivered over a 2-year period during extensive remediation.

    Result:  A smart, risk-based decision framework the company still runs today - delivered, in the client’s words, with “a calm, steady, systematic, and empathetic demeanor.” Not only was the Warning Letter lifted, it continues to be easily defensible and inspection-ready, plus internal capabilities were established that outlasted the engagement.

  • Situation:  An established device company faced a 483-driven CAPA requiring an independent conformance review of its risk files.

    What we did:  Led a protocol-driven review of 42 device risk analyses against ISO 14971, ISO 13485, and 21 CFR 820 / QMSR, producing 701 auditable findings, a 483 crosswalk, and a top-five systemic remediation plan sequenced by clinical consequence.

    • FDA 483 crosswalk mapped 100% of findings to standing observations (60% recurrence match).

    • Designed a protocol-driven, repeatable review methodology and managed the controlled review record end to end — finding logs, conformance checkpoints, dashboards, and cohort reconciliation — for zero-error deliverables.

    • Authored executive deliverables including a consolidated gap analysis report, ranked top-five systemic remediations, and 483 theme roll-ups, translating technical findings into root-cause-based recommendations.

    Result:  21 high-priority patient-safety issues and 228 high-priority regulatory compliance issues elevated and sequenced for inspection readiness, with zero-error, audit-ready deliverables.

  • Situation:  A surgical adjunct and implantable device company needed to launch a slate of new products — hemostats, adhesion barriers, orthobiologics, tissue-based devices — without disrupting supply and while reducing cost.

    What we did:  Guided large cross-functional teams through development to the latest FDA, MDR, and ISO standards: Voice-of-Customer and human-factors work, end-to-end traceability, optimized internal processes, and risk-based verification and validation including large-scale process validation.

    • Multiple events with surgeons and nurses for a wide variety of surgical applications

    • Partnerships with marketing and commercial organizations to provide training and competitive material to boost sales

    • Developed requirements and unlocked optimizations to maximize efficiency, throughput, environmental impact and exceed cost reduction efforts

    • Developed and qualified designs, fixtures, labeling

    • Successfully eliminated major historical customer complaints

    Result:  A seamless launch with no supply disruption and reduced cost — that also eliminated major long-standing customer complaints rooted in the previous design.

    • Held the quality system audit-ready and every regulatory obligation intact throughout the transition - post-market surveillance, field action, and CAPA/NC/audit processes ran uninterrupted - while managing certificate disposition, regulatory notifications, and device-listing updates.

    • Turned a complex decommissioning strategy into executable timelines, aligning Manufacturing, Quality, Engineering, IT, Facilities, and Regulatory around one plan.

    • Protected data integrity and long-term compliance - migrated IT, data, and records against GxP and 21 CFR Part 11 requirements, with validated long-term retention of controlled records.

    • Preserved traceability and supply continuity - dispositioned finished goods, raw materials, and stability samples, and resolved supplier NCs/SCARs and agreement updates.

    • Closed out equipment, facilities, and assets cleanly - inventories, final calibrations, and redeployment/sale/scrap with planned facility and utilities handover.

  • Created, trained and implemented integrated design control and risk management processes and files in accordance with EN ISO 14971:2012 and defined timelines for a Start-Up In-Vitro Diagnostic company.

    • Risk Management process development including tools and work instructions

      • Training development and deployment

    • Design Control process development including tools and work instructions

  • Created, trained and implemented quantitative risk management process and files in accordance with EN ISO 14971:2012 and defined timelines for an industry leading multi-million dollar Urology and Pelvic health company to support lifting FDA Warning Letter.

    • Risk Management process development including tools and work instructions

      • Training development and deployment

    • Risk assessment FMEA application

      • Requirements mapping to Failure Modes and linkages to Hazards and Harms

      • Causal Chain occurrence and probability calculations

    • Risk/Benefit Quantification concept, calculations and acceptability conclusions

    • Coding on complaint data fed to risk assessments

  • Created, trained and implemented integrated design control and risk management processes and files in accordance with EN ISO 14971:2012 and defined timelines for an established multi-million dollar molecular diagnostic company.

    • Risk Management process development including tools and work instructions

      • Training development and deployment

    • Design Control process development including tools and work instructions

Reviews

Built our global risk-management program

We are writing this letter on behalf of our professional experience with MEDEVEX.  We are currently a part of the Quality Management team at a leading In-Vitro Diagnostic medical device company.  We have collated our collective experience together to provide you a comprehensive description of the end result achievements, demeanor and impact to the business. 

MEDEVEX created the Risk Management program for our company, translating ISO 14971 into a corporate procedure which had to be operable for multiple sites, manufacturing different products across the globe.  The systematic approach and ability to see the big picture allowed MEDEVEX to create the necessary risk management infrastructure for our legacy products; in order to ensure that our risk management program is helping our business make smart risk based decisions.  This effort included leading a cross-functional team and subject matter experts in creating over 60 of the following deliverables:

  1. product safety references (which indicate the hazardous situations and severity of harm associated with the hazardous situations for each of our products),

  2. system risk assessments (which is a high level document including all of the known failure modes, occurrence rates of the failure modes, and hazards associated with that failure mode, for each of our products) and

  3. established the risk management folders for all products along with the overall risk management plan (a single plan covering 60 products rather than 60 repetitive plans thus reducing future document updates and approvals).

MEDEVEX also ensured that the risk management program would be self-sustainable.  A new internal role known as “risk management specialist” was created and an extensive curriculum was developed enumerating the requirements to become a risk management specialist.  Lastly, MEDEVEX took 20 or so associates through the journey of becoming a risk management specialist certification.  MEDEVEX also led the alignment of the risk management program to the process validation program and other design control elements. 

All of this was performed during a time of extensive remediation.  Introducing a new element to a global quality system is a challenging activity, especially when there is legacy product lacking the needed knowledge infrastructure to support that quality system element.  MEDEVEX consistently and gracefully carried out this 2 year process with a calm, steady, systematic, and empathetic demeanor.

Quality Management team, leading IVD company

Strategic leadership that still owned day-to-day execution — and delivered.

Aaron consistently demonstrated exceptional leadership, strategic thinking, and a strong commitment to driving results. Throughout the experience, Aaron proved to be highly capable and reliable, playing a critical role in advancing our product development and launch initiatives.

One of Aaron’s greatest strengths is his ability to think strategically while remaining deeply engaged in day-to-day execution. He excels at anticipating challenges, identifying opportunities, and aligning cross-functional teams around clear and actionable plans. Aaron approaches every project with focus, discipline, and a genuine desire to deliver high-quality outcomes.

In addition to technical and strategic capabilities, Aaron is an outstanding team leader. He manages teams with clarity and accountability, ensuring each member is supported while maintaining high performance standards. Aaron’s leadership has been instrumental in building a collaborative, solutions-oriented environment.

Overall, Aaron is a hardworking, strategic, and highly effective leader who consistently delivers results.

Product development & launch partner