Sterility Assurance
Ethylene Oxide
Our sterilization consulting services assist manufacturers with EO validation planning and documentation, including re-qualification studies and assessment. We can address product or process changes impacting sterilization. Let Device 2 Market improve your sterilization process and documentation to avoid high-risk non-compliance issues.
Gamma Radiation
Device 2 Market consultants are experts in radiation processes, including gamma irradiation. We can plan your sterilization strategy and write validation protocols and reports for regulatory compliance. Troubleshooting potential risks in testing is our specialty.
E-beam
Our team also specializes in e-beam irradiation, which is more and more in demand. Let us plan and validate the sterilization process that optimizes the performance and durability of your product.
Contract Sterilizer Auditing
Our auditing team specializes in contract sterilization processes and can provide expert input to your supplier quality management program. Device 2 Market will identify and mitigate process and quality risks that may impact your product.
Sterile Product Release
Let us develop your internal sterilization program, including validation, re-qualification, supplier agreement, and sterile product release requirements. Our team works efficiently to ensure your company meets industry standards and regulatory requirements.