_edit.png)
Sterilization
Sterilization Consulting
We provide expert consulting services for sterilization of medical devices using Ethylene Oxide (EO), Radiation (Gamma or Electron Beam), and Steam. Our support spans the full validation lifecycle — from protocol design to audit readiness — in line with international standards such as ISO 11135, ISO 11137, and ISO 17665.
We help manufacturers achieve compliant, effective, and reproducible sterilization processes tailored to their products and production setups.
Packaging
Sterile Barrier Systems
We provide comprehensive packaging validation services for terminally sterilized medical devices, in full alignment with ISO 11607 and ISO 16775 standards. From design qualification to final packaging verification, our experts ensure sterile barrier integrity, usability, and regulatory compliance.
QA / RA
Quality Assurance and Regulatory
We support medical device manufacturers in building, improving, and maintaining robust Quality Management Systems (QMS) — in full alignment with ISO 13485, EU MDR, and FDA requirements. Whether you're preparing for an inspection, facing a non-conformance, or setting up a new facility, our experts provide hands-on guidance and strategic oversight.
Microbiology
Microbiology Support
We offer microbiology consulting and testing support for medical device manufacturers who require sterile products. From bioburden determination to sterility testing and environmental monitoring, we ensure your processes are microbiologically sound and inspection-ready, in line with ISO 11737 and ISO 14698.
We don’t just deliver results — we help you understand them, act on them, and defend them during audits.
