A material supplier that ensure quality, capacity while meeting the most stringent regulations
Manufacturers of long-term medical implants (defined as devices inserted in the human body for 29 days or more) use silicone ingredients and formulations to make a wide range of products, such as tubing and drains, drug delivery systems, pacemakers, vaginal rings (IUD devices) and audiology applications. Silicones used in long-term implants must always be biocompatible, reliable, precise, flexible and durable, efficiently ensuring the protection of sensitive components from corrosive body fluids.
Manufacturers also expect their silicone suppliers:
To be attentive to their needs to meet changing market demand
To manufacture their products in impeccable clean rooms that meet the highest standards
To ensure procurement with available inventory and reliable delivery services
To provide support in regulatory matters, with access to documentation and certification to meet healthcare requirements.
Investing since long in the medical implant market
Elkem Silicones has made significant investments in healthcare ingredients and formulations for several years and is developing its industrial property portfolio in long-term medical implants. Our products have been validated that they meet applicable ISO 10993 or USP biocompatibility testing requirements. Our ISO 9001-certified manufacturing facility in the US is equipped with ISO 7 clean room manufacturing and ISO 8 clean room packaging and our quality-control systems are managed to comply with standards for long-term medical implants.
Commited to allow you to achieve your goals in the long-term medical implant sector
Our Silbione® Biomedical grade ingredients and formulations meet the highest quality standards. They are custom-designed to provide dependable and safe materials for patients and final users, while being easy to process and cost effective for manufacturers. Our teams are dedicated to working closely with manufacturers, often in long-term R&D partnerships, to provide them with the right products and personalized services.
We are working today on R&D to guarantee current and future needs by developing new products that meet evolving market demand and regulatory requirements. When working with us, you will be in touch with R&D specialists, regulatory experts, qualified technicians and responsive sales and logistics professionals.
To make sure we deliver on time and to your specifications, we have a secured supply-chain scheme to ensure uninterrupted procurement. Our products are monitored continually to comply with Master Access Filing (MAF) requirements with major public health authority bodies, including the
FDA in the US.
In short, we are committed to providing you with the products and services you need to allow you to achieve your goals in the long-term medical implant sector.