Traditional CROs fragment device development with costly hand-offs and learning curves. Veranex unites the essential disciplines for medical device & diagnostic development under one roof from sketch to evidence-generation to market launch.
All connected. All aligned. All accelerating your path to market—delivering breakthrough devices and diagnostics that improve patient lives sooner.
Breakthrough innovation requires more than great solutions; it demands deep expertise and insight. Veranex packages outcome-driven solutions with 25+ years of specialized knowledge across major medtech categories, delivering integrated capabilities that solve your most pressing challenges faster and with greater certainty.
Purpose-built solutions. Proven results. User & Patient-centered innovation.
Whether you're transforming patient care or disrupting entire therapeutic categories, innovation requires more than great science, it demands velocity. Veranex was founded to bridge the gap between visionary concepts and market reality, combining proven expertise with agile execution to accelerate the innovations that matter most.
We are the Innovation CRO.
Legacy of excellence. Proven execution. Patient impact accelerated.
Plan Your QMSR Transition and Strengthen Your Quality System
30-mins with our experts. Limited spots available.
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Stay Ahead of QMSR and Upcoming Inspections
The FDA’s Quality Management System Regulation (QMSR) will take effect on February 2, 2026 and align U.S. quality system expectations with ISO 13485. For many teams, this is also a chance to address long standing quality and regulatory challenges, not just a compliance update.
Your time is limited, so we keep this conversation focused. Depending on your priorities, the consultation can cover topics such as:
A quick read on your QMSR readiness and where you may need deeper assessment
How your current Quality Management System aligns to QMSR and ISO 13485
Regulatory implications for upcoming submissions and inspections
Where design controls, software, cybersecurity, and postmarket data need stronger links
Practical options for phasing changes without disrupting day to day operations
For your consultation, Naghmeh will be your first point of contact. She will review the information you share, clarify your priorities, and then schedule time with the best subject matter expert to support your specific products and challenges.
Naghmeh brings more than 30 years of regulatory and quality experience across global medical devices, including cardiovascular technologies, digital health, AI enabled solutions, and a range of therapeutic devices. Her background spans design assurance, verification and validation, risk management, regulatory submissions, CE marking, QMS implementation, postmarket compliance, and process validation with contract manufacturers.
Naghmeh Nouri
Executive Director, Regulatory and Quality Services
Regulatory and Quality Support Across the Product Lifecycle
The consultation is a starting point. From there, we can support your team wherever you have the greatest need, from strategy to execution.
From regulatory strategy and submissions, through design and development support, postmarket and vigilance, or internal audits and training, our teams are ready to partner to meet your goals.
