Why Work With AdvaSaf?
We provide comprehensive support to our customers during the entire sterilization process, offering an extensive array of packaging, manufacturing, testing, and validation services. Our streamlined operational setup allows us to ensure quick turnaround times for both small and large-scale production and shipping of medical and combination devices. Leveraging our global distribution capabilities, we facilitate international expansion for your products, catering to a diverse range of customers worldwide.
ISO 13485:2016 Certified Medical Device Quality Management System certification guarantees that your product will experience enhanced performance through the consistent delivery of safe and high-quality medical devices and services, ensuring adherence to the highest industry standards
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ISO 27001 certification guarantees acknowledgment of Advasaf's commitment to upholding robust information security management systems. This globally recognized standard signifies an unwavering dedication to safeguarding sensitive data, maintaining the integrity and confidentiality of information, and mitigating potential risks and vulnerabilities.
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ISO 9001 certification guarantees we meet the benchmarks for quality management systems across various industries. This certification serves as a testament to Advasaf's unwavering commitment to delivering products and services that consistently meet customer and regulatory requirements, while continually striving for operational excellence and customer satisfaction.
Strategically situated in the heart of the Midwest, our central location offers an array of advantages for manufacturing and sterilizing products, providing unparalleled convenience for our esteemed clientele. Capitalizing on our close proximity to major highways and key transportation hubs, we effectively minimize shipping durations, ensuring swift and efficient product delivery for our valued customers. Indeed, our prime location serves as a cornerstone of our commitment to delivering exceptional service and operational excellence.
Contract Sterilization
Emphasizing our commitment to delivering exceptional service, we specialize in providing comprehensive global contract sterilization and microbial reduction services. Employing a technology-agnostic approach, we leverage an array of industry-leading radiation and gas technologies to ensure the highest standards of product sterilization. Our advanced and meticulously curated sterilization processes are tailored to meet the unique needs of diverse industries, including medical device manufacturers, pharmaceutical companies, consumer goods producers, and industrial product suppliers. With a focus on precision and efficacy, our sterilization services adhere to stringent regulatory standards and global best practices, offering our clients the assurance of product safety and quality on a global scale. Trust us to safeguard your products and ensure their adherence to the most rigorous sterilization protocols, enabling you to maintain the highest levels of safety and compliance across your product portfolio
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Please reach out to us to see how we can sterilize your product.
Testing Services
Our comprehensive testing and validation services are designed to bolster the AdvaSaf sterilization process, encompassing meticulous examination of microbiological factors, precise analytical assessments, and comprehensive product and packaging testing. Adhering to Good Laboratory Practices (GLP) standards, we ensure the highest levels of safety and efficacy, consistently meeting and exceeding industry regulations. Trust us to support your product throughout the AdvaSaf sterilization process, with our meticulous microbiological, analytical, and product & packaging testing services.
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Please reach out to us to discuss all of your product testing needs.
Contract Assembly
Our comprehensive manufacturing operations encompass a wide range of activities, including the procurement, assembly, filling, labeling, and final packaging of advanced medical devices and combination products. Our adept team can effectively handle various types of packaging materials, ensuring flexibility and compatibility with diverse product specifications. Additionally, our state-of-the-art Class 7/8 cleanrooms guarantee adherence to stringent industry standards, ensuring an environment of optimal cleanliness and precision during the manufacturing process. Should your team require additional support for your sterilization operations, we are well-equipped to provide comprehensive assistance and expertise.
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Please reach out to us for our offerings related to your products.
Global Distribution
Operating with a global presence that spans across various continents, our robust distribution network is strategically positioned to efficiently serve diverse markets around the world. Leveraging our extensive network and expertise, we have established strategic partnerships with local entities in multiple countries, ensuring seamless and efficient distribution tailored to the unique demands of various regions. By actively engaging with local partners, we have streamlined our operations to effectively navigate the complexities of diverse international markets, fostering a culture of adaptability and responsiveness to specific regional requirements. Our commitment to delivering timely and reliable distribution services remains unwavering, enabling us to effectively meet the evolving needs of our global clientele and ensure the timely delivery of essential medical devices to those who need them the most.
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Get in touch with us today to unlock new avenues for your business expansion and product distribution globally.
Consulting
Our holistic consulting services offer a comprehensive suite of solutions tailored to meet the diverse needs of the medical device industry. With a focus on ensuring the highest standards of product quality and compliance, we provide specialized guidance on packaging, sterilization, and distribution services, enabling our clients to navigate the intricate landscape of the healthcare sector with confidence and precision.
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Our team of seasoned professionals, well-versed in regulatory affairs, works tirelessly to ensure that all medical devices meet stringent industry standards and regulatory requirements. By offering comprehensive regulatory affairs services, we assist our clients in obtaining the necessary certifications and approvals, facilitating smooth market access and product distribution across various global markets.
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With our robust expertise in the areas of packaging, sterilization, distribution, and regulatory affairs, we empower our clients to streamline their operations, optimize product performance, and uphold the highest levels of safety and efficacy. Our dedication to excellence and our unwavering commitment to regulatory compliance position us as a trusted partner in the journey toward delivering innovative and life-saving medical devices to individuals around the world.
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Contact us today to explore opportunities for expanding your business through our specialized consulting services.​​
Locations
AdvaSaf HQ
280 Regency Ct, #401
Brookfield, WI 53045
USA
AdvaSaf Sterilization and Manufacturing
2485 Corporate Circle,
East Troy, WI
USA