Ethylene oxide (EtO) Sterilization, restore compliance & answer notified body

Logical, cost effective, multisite coordinated, compliant, regulatory & documentation support


  • Prompt replies on two deficiency reports (Process/Packing) from the notified body.

  • Obligated for expertise to detect compliance void in documents, reports, protocols & data.

  • Critical compliance upgrade on sterilization process (ISO:11135, AAMI TR 16 & TR27).

  • Urgency for coordinated dialogue with manufacturing & overseas contract sterilization sites.


  • Harmonized dialogue with Manager, Specialists, RA and contract sterilization site.

  • PQ protocol and data review including test reports: IPCD, sterility, bioburden & residue limit.

  • Justification and addition of compliance content in revised VPL, PQ protocol & test reports.

  • Compliant and apt replies to the questions in the deficiency reports.

  • Rebuilding compliance on incubation period of PCDs as per new regulatory expectations.

  • Improved expectations annual validation, routine sterilization & release controls of devices.


  • Dependable technical dialogue, engagement with client & contract sterilization site.

  • Competent technical documentation & process support.

  • Accurate analysis on approaches, incorporation of rationales & worst-case scenarios.

  • Pertinent scientific replies & confirmation to the notified bodies.

  • Reclamation of compliance in a very efficient way and on time.

  • Up-to-date handover of validation, process plans, test reports & regulatory documents.

contact for this case

Anders Helmer Nielsen

Mobile: +45 5099 8328