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Validation Services

Turnkey validation for sterile label claims

Complete EO sterilization validation programs in accordance with ISO 14937. From protocol development through final reporting, we coordinate testing, manage third-party laboratories, and maintain documentation integrity throughout.

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Validation programs built for regulatory confidence

We develop and execute complete ISO 14937 validation programs, from worst-case rationale through final qualification. Every decision is documented and defensible.

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Scientifically justified worst-case strategy

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Structured load configuration and rationale

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Coordinated third-party laboratory testing

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Audit-ready documentation at every stage

What We Do

Comprehensive EO validation programs

Complete ethylene oxide sterilization validations designed to support sterile label claims with defensible scientific rationale and regulatory clarity.

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Worst-Case Strategy Development

Challenge device approaches and worst-case logic aligned with product risk and material compatibility.

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Load Configuration & Rationale

Structured load design supported by documented rationale for defensible validation logic.

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iPCD & ePCD Resistance Studies

Resistance testing to confirm biological indicator challenge and process effectiveness.

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Overkill Method Validation

Half-cycle or full-dose overkill approaches selected based on your regulatory strategy.

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Cycle Development & Qualification

Controlled cycle development, optimization, and final qualification aligned with ISO 14937.

How It Works

You approve the protocol and final report. We manage everything in between.

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We assess your device, packaging, and regulatory pathway

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We develop the validation protocol and present it for your approval

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We execute testing, coordinate third-party labs, and manage data integrity

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We deliver the final validation report with audit-ready documentation

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We stay available to support audits and regulatory questions

Our Process

A practical, risk-based approach to every project

We apply the same disciplined framework whether you need a single feasibility run or a full validation program.

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Regulatory Compliance

Every process decision is supported by relavent FDA and ISO guidance.

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Proportionate to Risk

Controls scaled appropriately to your product and regulatory path.

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Audit-Ready

Documentation designed to withstand regulatory scrutiny.

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Adaptable

Validation strategies designed to support evolving products and production needs.

Standards

Registered and audited for medical device work

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ISO 13485 Certified & FDA Registered

Est. No. 1064858

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FDA Innovation Challenge 2 Winner

Recognized for responsible innovation

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Environmental Stewardship Award

Small Business recipient

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NC Permit Exemption

Exceptionally low emissions

FAQs

Validation

What defines product validation?expand_more
Regulators define validation as documented evidence that a specific process will consistently produce a product meeting its predetermined specifications and quality attributes. It is the foundation for any sterile label claim in healthcare.
What goes into a validation protocol?expand_more
A validation protocol includes worst-case rationale, load configuration documentation, biological indicator resistance studies, cycle parameters, acceptance criteria, and a detailed test plan. Every element is designed to be scientifically defensible and audit-ready.
Do you generate the protocol?expand_more
Yes. We develop the complete validation protocol, manage execution including coordination with third-party test laboratories, and deliver the final validation report. You approve the protocol and final report. We manage the execution in between.

Single-Lot Release

What is a single-lot release?expand_more
A single-lot release is a streamlined study for devices in early development heading into clinical trials. It allows your lot to carry a sterile label without full validation, typically conducted under an Investigational Device Exemption (IDE).
How many devices do you need?expand_more
The number depends on your study design, but we work with small quantities regularly. We will help you determine the minimum needed to generate the data required for your submission.

Adoption

Do I need full revalidation for a new device?expand_more
Usually no. We evaluate your new device against the existing validated process by comparing design, materials, sterile barrier, and load configuration. If the change is minor, a paper review may be sufficient.

Packaging

Do you offer shelf-life validation?expand_more
Yes. Most teams have already validated their sealer at manufacturing or a contract facility. We establish expiration dates by testing your product in its actual packaging system under real-world conditions, including sterilization, shipping, and handling.
What is shipping simulation testing?expand_more
Shipping simulation testing evaluates the integrity of your sterile barrier system after exposure to the physical stresses of transportation. It is a critical component of demonstrating that your packaging maintains sterility through the distribution chain.

Ready to start your validation program?

Tell us about your device and regulatory pathway. We will outline a validation strategy and timeline.

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