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
Executive Director, Quality Systems
Ramona Field brings three decades of distinguished medical device industry expertise to her role as executive director of quality systems at Veranex, where she leads strategic quality initiatives across the full spectrum of medical device classifications. Her comprehensive experience encompasses quality systems development, regulatory compliance, and strategic planning for both U.S. and international markets. Ramona fosters open dialogue to understand client needs and concerns. Her collaborative approach to building strategic partner alliances, combined with her deep understanding of global quality requirements, positions her as a crucial resource for medical device manufacturers navigating complex quality and compliance challenges throughout their product lifecycles.
Sasha Rassoli
Sr Manager, Quality Engineering
Sasha Rassoli is a Senior Manager of Quality Engineering with over 10 years of experience in the medical device industry. A recognized expert in process validation, design transfer, manufacturing, process development, design controls, and risk management, Sasha has worked on a wide range of products, including IVDs and Class I, II, and III medical devices. Sasha is an ISO 13485:2016 Lead Auditor and Lean Six Sigma Black Belt certified, bringing a deep understanding of quality management systems and continuous improvement to every project. Sasha’s commitment to excellence ensures strong safety and performance standards, while tailoring solutions to align with each client's specific goals and needs.
Cédric Razaname
Director, Quality and Regulatory Affairs
Cédric Razaname brings over eight years of specialized expertise in medical device quality systems and regulatory compliance. His comprehensive approach to quality management and regulatory strategy has proven instrumental in guiding companies through complex certification processes and regulatory inspections. As a skilled leader in the medtech sector, Cédric excels in implementing robust quality management systems, managing regulatory submissions, and fostering continuous improvement initiatives. His core strengths in risk management, stakeholder engagement, and critical thinking, combined with his dedication to coaching and mentoring, make him an invaluable resource for medical device manufacturers navigating the intricate landscape of global regulatory requirements and quality standards.
Case Studies
The Impact of Medical Device Process Validation Experience
Case Study
Situation
A mid-sized medical device company needed full process validation for its Class II oncology device to meet aggressive FDA 510(k) and CE Mark submission deadlines. Lacking the necessary in-house expertise and resources, they sought external support to ensure their regulatory submissions were successful and on schedule.
Successes
- Launched 3-months ahead of schedule by aligning validation activities with ongoing design transfer milestones.
- Zero major findings during subsequent FDA inspection and Notified Body ISO 13485 audit.
- Successfully demonstrated process robustness and validation, enabling confidence in product quality and reproducibility at launch.
- Strengthened the client’s internal systems by providing templates and training for future validation activities.
Services by Veranex
- Embedded validation specialist to co-lead efforts with internal teams
- Development of a comprehensive risk-based Validation Master Plan (VMP)
- Authoring and execution of installation qualification (IQ), operational qualification (OQ), and process qualification (PQ) protocols for critical manufacturing equipment
- Coordination and oversight of environmental monitoring
- Documentation and support for regulatory submissions
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.

Quality Management Systems (QMS)
Implement ISO 13485 right the first time, pre-empting audit findings and reducing months of off market-clearance timelines.

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

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

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.



