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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Ramona Field

Executive Director, Quality Systems

Sasha Rassoli

Sr Manager, Quality Engineering

Cédric Razaname

Director, Quality and Regulatory Affairs

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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

Human Factors & Usability

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

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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.

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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.

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