Applied Silicone offers comprehensive material compendia for long-term implantable silicone products3 September 2013
Applied Silicone Corporation, a global supplier of implantable silicone material for the critical healthcare and medical device markets, announces the availability of material compendia detailing the physical, chemical, and biological testing of the raw material specific to each long-term implantable silicone product offered by the company.
This valuable service provides the user with an extensive summary of the supporting documentation available, in electronic format, for regulatory review and submissions for Class II and Class III medical devices.
Material compendia allow device manufacturers to avoid redundant pre-clinical physical, chemical, and biocompatibility testing of the material for regulatory submissions, such as 510(k), IDEs, and PMA pre-market notifications. Each compendium is a highly organized summary of physical property data, chemical properties, and the biological testing conducted on each product.
The documentation is supported with references to corresponding Master Access Files (MAF) that are registered with the U.S. FDA. For international medical device submissions, the compendium is customized to address the requirements set forth by regulatory bodies in the country of submission.
"Applied Silicone's regulatory team has assembled comprehensive directories that are both product and customer specific," said Annabelle Cortez, quality manager of Applied Silicone Corporation. "An organized summary of material testing is an indispensable guide for regulatory reviewers."
To learn more about Applied Silicone's products and services and to preview a sample compendium index please visit, www.appliedsilicone.com
About Applied Silicone Corporation
Applied Silicone is a global supplier of implantable silicone material for the critical healthcare and medical device markets. The company specializes in long-term implantable silicone proven with 25 years of successful clinical use. Products include high purity silicone gels, elastomer dispersions, adhesives, LSR, HCR, lubricant coatings, primers, fluids, sheeting, and custom formulations. Designed to meet FDA and ISO 10993 biocompatibility requirements within an ISO 9001:2008 certified quality system.
Wells Bruning Communications