We are fully committed to being your world-class, objective-focused CDMO partner in the development and delivery of innovative solutions to enhance user experience
Advanced Individual Solutions for Diagnostic Requirements
Stevanato Group can comprehensively support your specific needs for point-of-care devices, in-vitro diagnostic (IVD) consumables and medical solutions, thanks to its team of experts in development, injection molding, automated assembly and display. Our unique approach as a one-stop-shop provider means we can cover the entire product life cycle, from concept definition to industrial delivery and final packaging – offering an unprecedented set of diagnostic solutions to pharma and healthcare companies for faster time to market and reduced total cost of ownership.
Established player in the market
With over 110 years of company history, we have unique knowledge of large-scale injection molding and manufacturing, as well as complex manual and automated assembly. We combine the highest quality standards and economies of scale for large volumes and high product complexity, through our production sites in Germany and the United States.
Flexible CDMO approach
Thanks to our integrated approach, we can harmonize all the different development processes from the definition phase to the production and global supply of your products. You can count on decades of experience in development and industrialization of complex systems.
Modular processes allow customers to enter at different project stages, according to their needs and requirements.
Learn more about our in-vitro diagnostic and medical solutions
Development, Industrialization and Contract Manufacturing: Explore our full offering
Product Development & Engineering
- Definition and documentation of product requirements.
- Development of your product, including your ideas, using a systematic and product-oriented development approach.
- Usability studies, mechanical and functional testing, risk management and verification. Providing input for the design history file and design master file.
- Development of concepts and mock-ups, based on proven manufacturing knowledge and experience.
- Project management support throughout the whole product life cycle.
Process Development
- Planning of the entire production process, including molding, automated assembly and final assembly.
- Requirement-based development from manual to fully automated assembly and ancillary processes involving Stevanato Group device assembly equipment resources and competencies.
Production
- 16,900sqm of controlled and cleanroom areas (GMP, class ISO 8 and ISO 7) in Germany and in the US
- 200+ high-precision injection molding machines available at our sites in the US and Germany.
- Possibility of up to 128 cavities, clamping force 20t – 500t.
- 40+ assembly installations from manual to full automation.
- 24/7 production from small scale to mass production.
- Manufacturing know-how and proven production experience in mechanics and electronics.
- Product-specific in-line inspection.
- In-house repair and maintenance (including preventive mold maintenance).
- Individual tool maintenance strategies, with spare parts availability to ensure production continuity.
Final Assembly, Labeling & Packaging
- Fully automated flexible, scalable and modular assembly of components, including electronic PCB and displays.
- Finishing technologies such as decorated and functionalized surfaces.
- Final testing, including camera inspection.
- Final assembly operation.
- Integrated, tailor-made packaging and labeling.
Quality
- ISO 9001, ISO 15378, ISO 13485 certified quality management system compliant with 21 CFR Part 820 and FDA audited.
- Six-Sigma approach throughout the entire industrial product life cycle.
- Risk-based qualification and validation (DQ, IQ, OQ, PQ).
- State-of-the-art testing technologies, including computer tomography, and tactile and optical testing.
- In-house analytical services provided by accredited Technology Excellence Centers.
- Product registration support.
Production Sites for Diagnostic
- Europe
- Asia
- America
