Validation programs built for regulatory confidence
We design ISO 14937 validation programs around the conditions most likely to challenge your device—not simply the configurations that are easiest to test. We evaluate your product in detail, then develop a compatible load configuration that maximizes throughput while establishing a scientifically defensible worst case. We carry that rationale through protocol development, laboratory testing, qualification, and the final report.
The result is more than a completed validation package. It’s a documented chain of technical decisions your team can explain and defend.
Scientifically justified worst-case strategy
Structured load configuration and rationale
Coordinated third-party laboratory testing
Audit-ready documentation at every stage
Comprehensive EO validation programs
Complete ethylene oxide sterilization validations designed to support sterile label claims with defensible scientific rationale and regulatory clarity.
Worst-Case Strategy Development
Challenge device approaches and worst-case logic aligned with product risk and material compatibility.
Load Configuration & Rationale
Structured load design supported by documented rationale for defensible validation logic.
iPCD & ePCD Resistance Studies
Resistance testing to confirm biological indicator challenge and process effectiveness.
Overkill Method Validation
Half-cycle or full-dose overkill approaches selected based on your regulatory strategy.
Cycle Development & Qualification
Controlled cycle development, optimization, and final qualification aligned with ISO 14937.
You approve the protocol and final report. We manage everything in between.
We assess your device, and regulatory pathway
We develop the validation protocol and present it for your approval
We execute testing, coordinate third-party labs, and manage data integrity
We deliver the final validation report with audit-ready documentation
We stay available to support audits and regulatory questions
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.
Understand the Product
Evaluate the device, materials, configuration, and intended sterilization process.
Define the Risk
Identify the conditions and variables that challenge the process and determine what must be demonstrated.
Build the Strategy
Develop a proportionate testing and validation approach supported by scientific rationale and applicable standards.
Document the Rationale
Carry the technical justification through testing, qualification, and reporting so the decisions are clear and defensible.
Registered and audited for medical device work
ISO 13485 Certified & FDA Registered
Est. No. 1064858
FDA Innovation Challenge 2 Winner
Recognized for responsible innovation
Environmental Stewardship Award
Small Business recipient
NC Permit Exemption
Exceptionally low emissions