Solutions for Your Success

Mission

MEDEVEX provides highly impactful consultation services with decades of experience in highly regulated industries. MEDEVEX has accumulated substantial program leadership, engineering development, process improvement and quality management systems knowledge and experience. We are passionate about helping clients WIN by meeting their business critical objectives on time and on budget. MEDEVEX works closely with medical device and biopharmaceutical companies on meeting evolving customer unmet needs and FDA, MDR and ISO standards. By gaining clarity on the problem being solved and optimizing workflows MEDEVEX is able to unlock greater levels of organizational efficiency, leading to increased return on investment for our valued clients.

Services

Project / Program / Portfolio Management (PMO)

We work collaboratively to 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

Our culture is rooted in the use of agile lean continuous improvement with critical thinking and problem solving principles to ensure the right problems are solved the first time and to ensure hidden factories and other forms of waste are eliminated. We emphasize high communication, awareness and a proactive management of risks to program success with immediate tactical and actionable countermeasures so the teams and clients we support can succeed.

Quality Management Systems (QMS)

Quality is at the center of everything we do. We perform gap assessments to create Quality Plans aimed at integrating and improving company Standard Operating Procedures (SOPs) and templates to enable competitive compliance with evolving directives, regulations and quality standards. We provide guidance throughout the implementation process so Quality Plans close on time.

  • Quality Management Systems per ISO 13485:2016

  • Design Controls per 21 CFR 820.30

  • Risk Management per EN ISO 14971:2012

  • Design Change per 21 CFR 820.40

  • Production and Process Controls per 21 CFR 820.70

  • Nonconformance per 21 CFR820.90

  • Complaint Handling per 21 CFR 820.196

  • Corrective and Preventative Actions (CAPA) per 21 CFR 820.100

  • Field Action / Recalls per 21 CFR 806

Development and Manufacturing Engineering

Our technical expertise extends 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

Rapid learning coupled with never being satisfied with the status quo is our engineering ethos. We strive to optimize Safety, Quality, Delivery, Cost and Productivity in the work we create. We follow a robust stage gate approach with key stakeholders and our Design Reviews are clear and concise for auditors and future teams to follow. The clients we serve are highly confident in our ability to overcome challenges and achieve results throughout the development, regulatory clearance and commercial launch processes.

Experience

    • Coordinated a cross-functional decommissioning program - turning the decommissioning strategy into manageable timelines across Manufacturing, Quality, Engineering, IT, Facilities and Regulatory stakeholders.

    • Maintained QMS and regulatory obligations (post-market surveillance, field action, CAPA/NC/audit processes) throughout the transition - ensuring continuity and certificate disposition while preparing regulatory notifications and device-listing updates.

    • Oversaw equipment, facility and asset dispositions which entailed creating equipment inventories, performing final calibrations, coordinating redeployment/sale/scrap using asset systems, and planning facility and utilities decommissioning and handover.

    • Executed IT, data and records migration - assessing GxP systems, developing IT decommissioning and data-migration/archival plans (including 21 CFR part 11 considerations), and ensuring long-term validated storage and retention of controlled records.

    • Controlled materials and supplier impacts - planning disposition or transfer of finished goods, raw materials and stability samples; handling supplier NCs/SCARs and supplier agreement updates; and maintaining traceability and protective measures during transfers.

    • Led an independent regulatory conformance review of 42 medical-device HRAs/HHEs under an FDA 483–driven CAPA, assessing conformance to ISO 14971:2019, ISO 13485:2016, and 21 CFR Part 820 / FDA QMSR; producing 701 auditable findings.

    • Built an FDA 483 crosswalk mapping 100% of findings to standing observations (60% recurrence match) and elevated 21 Level-5 patient-safety issues, sequencing remediation by clinical consequence to support inspection readiness.

    • 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.

  • Guided large cross functional core teams through the development of new medical devices to comply with the latest FDA, MDR and ISO regulations and standards for a wide variety of sterilized and biocompatible implantable products including passive hemostats, adhesion barriers, orthobiologics and bovine pericardium tissues.

    • Performed multiple Voice of Customer and Human Factors 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, maintained traceability and optimized internal processes in order to maximize efficiency, throughput, environmental impact and exceed cost reduction efforts

    • Developed and qualified designs, fixtures, labeling through risk based sample size design verification and validation, including large scale process validations

    • Successfully launched new products seamlessly without disruption while also eliminating major historical customer complaints

  • 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

  • Trained, mentored and implemented a remediated risk management process compliant to ISO 14971 and modified the Post-Market Notification process compliant to 21CFR Part 807 to support lifting FDA Warning Letter for a globally recognized multi-million dollar In-Vitro diagnostic company in assays and assay instrument platforms . 

    • Managed resources and timelines to assist multiple divisions across the globe to sunset FDA obligated interim controls

    • Process mapping integrating risk management with both pre-market design control and post-market design change

    • Supported multiple cross functional project teams during design change and risk documentation development activities to ensure the work was done right the first time and completed efficiently

    • Developed and provided in person risk management process and tool usage training content with best practice examples, exercises and assessment metrics for scientists, engineers and management

    • Identified, trained, mentored and certified Risk Managers and Specialists at multiple global sites

    • Created, reviewed, and approved over a thousand risk documents including risk management plans, medical product safety references, lower level FMEAs (use, design, and process), high level system risk assessment control tables, clinical risk benefit analysis (cRBA) and risk management reports in accordance with FDA obligated interim controls.

    • Reviewed, red-lined, and approved new pre-market notification procedures and decision trees compliant to 21CFR Part 807 Subpart E /809 /814 /860 /862 /864 /866

  • 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

TESTIMONIAL

To Whom it may concern:

 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. 

TESTIMONIAL

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.