Medical Device Excellence, Delivered.
Quality systems, program leadership, and design & manufacturing engineering for medical device and IVD teams from QMSR and ISO 13485 to risk management, remediation, and launch. Work with MEDEVEX
“MEDEVEX consistently and gracefully carried out this 2-year program with a calm, steady, systematic, and empathetic demeanor.”
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.
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.
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 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
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
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.
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.
“Aaron is a hardworking, strategic, and highly effective leader who consistently delivers results.”