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Outcome-Driven Solutions for Medtech Challenges

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.

 

Purpose-Built for Breakthroughs

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.

 

Turn Our Insights Into Your Impact

From early feasibility to commercialization, progress depends on the right decisions at the right time. Get confident in your next step with blogs, case studies, and expert insights that cut through complexity and move development forward.

 

Webinar

Prepare for FDA’s Evolving Inspection Approach

30 July 2026 | 11am – 12pm EST

 

Webinar Summary

Understand what FDA’s inspection shift means for your audit readiness plan

FDA inspections are becoming more risk-based, systems-focused, and data-driven, creating new pressure on quality systems, digital records, risk management, and inspection response teams. In this webinar, Veranex quality and regulatory experts will break down how FDA’s updated inspection approach is shaping expectations across medical device and combination product manufacturers. Attendees will learn where readiness gaps commonly appear, how to prepare for remote, hybrid, and on-site inspections, and how to strengthen inspection readiness before compliance risk becomes a finding.

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Paige Sutton-Smith

Sr. Manager, Regulatory Affairs & Quality Assurance

Speaker

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Elena Lucano

Sr. Manager, Regulatory Affairs & Quality Assurance 

Speaker

Webinar Learning Objectives

 

Evaluate

Assess your current quality systems and inspection readiness against FDA’s evolving expectations, including data integrity, digital records, risk management, and post-market processes.

Apply

Use practical strategies to prepare for remote, hybrid, and on-site inspections, from documentation readiness to front-room and back-room response planning.

Recognize

Identify common compliance pitfalls tied to the revised inspection approach and understand how to reduce avoidable findings before they become regulatory risk.

Who Should Attend

  • Quality Assurance & Quality Control Professionals (Managers, Directors, VPs)
  • Regulatory Affairs Professionals responsible for FDA submissions and compliance strategy
  • Manufacturing & Operations Leaders accountable for GMP compliance
  • Internal Auditors and Inspection Readiness Teams
  • Quality system, CAPA, supplier quality, and post-market surveillance teams

 

Learn from Specialists Who Work Inside Medtech Complexity Every Day

Veranex helps you navigate changes with confidence by providing comprehensive consultation, execution support, and quality system planning.