Documentation that withstands regulatory scrutiny
Our documentation is designed to clearly connect the sterilization strategy, scientific rationale, testing, results, and conclusions. Protocols, reports, and summaries are structured to support review by clients, auditors, notified bodies, and regulatory agencies.
Scientifically defensible protocols and reports
FDA Sterilization Master File on record
Clear, Organized Reporting
Records Retained for 15 Years
Documentation throughout the sterilization lifecycle
Protocol Development
Device-specific protocols documenting the validation strategy, scientific rationale, acceptance criteria, and testing requirements.
Audit Support
Technical and documentation support for customer audits, notified body reviews, and regulatory inspections.
Sterilization Documentation Support
Sterilization documentation and technical responses provided, as appropriate, to support client regulatory submissions and agency inquiries.
Master File Access
Access to our FDA Sterilization Master File to support applicable regulatory submissions.
Change Impact Assessment
Documented evaluation of product, packaging, process, or manufacturing changes and their potential impact on the validated sterilization process.
Historical Data Management
Controlled retention of sterilization, validation, requalification, and associated process records to support future review and assessment.
Credentials That Matter
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