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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.

 

Master Medical Device Process Validation with Confidence

Shift your perspective: Use medical device process validation not just to meet requirements, but to build a powerful competitive advantage.

Why Process Validation Matters 

A robust process validation is the foundation for a reliable, safe, and commercially successful product. Medical device process validation is about safeguarding patient health by documenting objective evidence that processes will consistently produce devices that meet all quality and performance specifications. These activities are more than compliance to U.S. (21 CFR 820.75) and EU/ISO 13485 § 7.5.6 but a critical business tool that reduces the risk of costly product recalls, minimizes batch failures, and builds lasting trust with both clinicians and regulatory agencies.

 

Validation lapse: Packaging-seal process not in control

 

Impact: FDA recall of multiple implants because a breached sterile seal “lead to loss of sterility of the device.

Validation lapse: Bioburden test method never validated

 

Impact: 2023 FDA warning letter to MedTech who “failed to adequately validate” its bioburden recovery method.

Validation lapse: Process validation a top 483 citation

 

FDA’s FY-2024 Form 483 spreadsheet shows 820.75 (Process Validation) remains among the most-cited QS violations for devices.

Comprehensive Process Validation Services for Medical Devices 

Transform process validation, from a regulatory requirement into a strategic advantage. Veranex integrates its validation specialists directly into your R&D and manufacturing teams to co-develop risk-based master validation plans that align with your timeline and resources.

Our goal is to achieve a safe, reliable, and trustworthy device with reduced delays, minimized risks of costly recalls, and support long-term product reliability. We proactively reducing risk early in the development cycle and identifying the critical parameters to ensure success and regulatory compliance by supporting each phase of the validation lifecycle to ensure the regulatory expectations are consistently met to have submission and audit confidence in the results.

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Sterilization Validation

Prove ISO 11135/11137 loads at worst case; half-cycle BI runs lock sterility upfront—no re-tests, no launch delays.

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Cleaning & Disinfection

AAMI TIR12 studies verify soils, extraction, and residual limits, cutting post-market complaints.

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Retrospective Validation

Leverage existing real-world data to satisfy FDA’s “least burdensome” path—shave months off prospective process validation.

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Software / CSV

Draft, test, and document SDLC controls so connected devices clear regulatory review with confidence in your device’s software reliability.

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IQ · OQ · PQ

Effectively verify installation and operating limits to produce a consistent product along with regular re-quals to keep your medical device process validation audit ready.

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Risk & Protocols

Map process risks, write master validation plans for seamlessly execution that meet the FDA / EU acceptance criteria before a single test is run.

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Meet the Team

Meet Your Process-Validation Experts 

ramona-field

Ramona Field

Executive Director, Quality Systems
sasha

Sasha Rassoli

Sr Manager, Quality Engineering
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Cédric Razaname 

Director, Quality and Regulatory Affairs

Case Studies

The Impact of Medical Device Process Validation Experience

Discover More

Related Services at Veranex

Human Factors & Usability

 

Eliminate critical use errors and pass summative validation thus enabling safer devices, stronger adoption, and faster regulatory green-lights.

Human Factors

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Quality Management Systems (QMS) 

 

Implement ISO 13485 right the first time, pre-empting audit findings and reducing months of off market-clearance timelines.

QMS Consulting

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Software Design & Development  

 

Dominate SiMD: integrate firmware, UI, and risk-classified software that meets IEC 62304 and adds value to your device’s experience.

Software Services

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Design & Manufacturing Quality 

 

Achieve V&V-ready designs and bullet-proof DHFs that clear regulators without costly rework.

Design & Manufacturing Quality

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Start Your Validation Scope Call

Get a tailored medical device process validation plan guided by our specialists. Outline a custom IQ · OQ · PQ roadmap that puts your device on a path to approval.