Over 10 years of experience in monitoring sterile medical devices based on ISO 11137-2 and -3
Expert in microbiological analysis and sterilization method development
One of the few experts who have both extensive technical knowledge and practical knowledge of the complete validation process of sterilization
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Our content and services may vary by location.
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Overview
- Availability
- Asap, 5 days/week, on-site & remote
- Qualification
- Diploma in Chemistry and Hematology
- Language Skills
- German (native), English (business fluent)
- Relevant Expertise
- Sterilization Validation, Medical Device Industry, Gamma & EtO Sterilization, Radiation Sterilization, ISO 11137 & 11135, FDA, Dose Mapping, E- beam, Clean Room, Microbiological Monitoring, Bioburden, Process Validation
Key-Facts
Extract from previous activities
Pharmaceutical Company, Germany
Expert Radiation Sterilization
Technical documentation for radiation sterilization
Product validation
Dose mapping
Biotechnology Company, Netherlands
Expert in Gamma Sterilization and Certification Processes
Technical documentation for gamma sterilization
Product validation
Support in the CE and ISO 13485 certification process for a class I product
Medical Company, Netherlands
xpert in Gamma Radiation and EtO Sterilization & Microbiological Processes
Consulting and Support for Sterilization and Microbiological Processes
Gamma and EtO sterilization; Audit preparation and microbiological validation, including gamma radiation
Medical Technology Company, Switzerland
Consultant Audit – Radiation Sterilization
Consulting for radiation sterilization (recertification and FDA inspection, zero FC; F483) and microbiological processes
Support as an external SME
Validation of a project for personalized 3D printed implants
Validation process support