Manuel Grandy Email & Phone Number

Based in Germany, SteriComp GmbH is an expert consultancy focused on the sterilization of medical devices. Our dedicated core team, supplemented by a network of specialized freelance consultants, collaborates closely to tailor our services to your unique needs.We serve global medical device manufacturers seeking to uphold or enhance the regulatory compliance and efficiency of their sterilization procedures. Our clients rely on us for proficient personnel and in-depth expertise for urgent projects or long-term outsourced partnerships.Our main fields of expertise are:​ - Sterilization validations for ethylene oxide- (ISO 11135), radiation (ISO 11137) and new modalities (VHP, ClO2, NO2 - ISO 22441, ISO 14937) - EO sterilization residuals studies (ISO 10993-7 incl. AMD1 for new-borns and children). - Reprocessing (FDA guidance and ISO 17664). - Development and validation of sterile barrier systems for terminally sterilized medical devices (ISO 11607). - Quality management processes related to sterilization (ISO 13485). - Plant engineering, maintenance and optimization of EO sterilization systems including EHS.Connect with us on LinkedIn and reach out if you're a medical device manufacturer with a particular project in mind, interested in a complimentary consultation, or a sterilization professional looking to collaborate. We're here to engage and assist you with your specialized needs.www.SteriComp.com+49 7326 27399 80Info@SteriComp.com