MEDICAL DEVICE
Ethylene oxide (EtO) Sterilization, restore compliance & answer notified body
Logical, cost effective, multisite coordinated, compliant, regulatory & documentation support
BACKGROUND
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.
Benefit
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.
Services
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
Email: ahn@amgroup.dk
