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At SteriComp, we deliver specialized consulting and validation services for medical device manufacturers across the globe.
Our expertise spans sterilization, microbiology, packaging, and quality systems — all designed to ensure your products meet international standards like ISO 11135, 11737, 11607, 13485, MDR, and FDA requirements.
Whether you’re launching a new product, preparing for an audit, or improving an existing process, we bring practical, compliant, and timely solutions to your regulatory challenges.
Global Experts in Sterilization, Microbiology, Packaging & QA for Medical Devices
​Who We Are & What We Do
We are a German consulting company specialized in sterilization of medical devices with a core team and further freelance sterilization experts who work in close consultation with us for your individual requirements.
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Our customers are medical device manufacturers worldwide who want to maintain or improve fulfillment of the regulatory compliance and efficiency of their sterilization processes and who need skilled staff and expertise for time-critical projects or also for permanent outsourcing.
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Our main fields of expertise are:
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- Sterilization validations for ethylene oxide- (ISO 11135) and radiation sterilization (ISO 11137).
- EO gas residual 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.
- Plant construction, maintenance and optimization of EO sterilization systems.
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OUR VISION
SteriComp GmbH strives to be the first contact of medical device manufacturers worldwide who need expertise and manpower for efficient and regulatory compliant processes in the field of sterilization of medical devices.
OUR MISSION
Working closely together with our customers, develop value added strategies on medical device sterilization processes and implement those strategies to maximize compliance and profitability
OUR VALUES
Integrity • Precision • Reliability • Global Thinking • Practicality
CORE TEAM
We are experienced professionals with complementary areas in sterilization and related fields:
Manuel Grandy
Managing Partner
Ümit Cakirgöz
Managing Partner
Our core team is completed with freelance sterilization experts who work in close consultation with us for our clients.
REFERENCES
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