Interplex Medical Quality Systems are established to comply with U.S. FDA requirements (21 CFR 800 et seq.), ISO 13485:2003, EU Medical Directives (including CE and technical file support) and other international requirements for all medical devices manufactured by Interplex Medical worldwide. Interplex Medical quality personnel have extensive U.S. and EU regulatory experience and have made FDA filings for 510(k) applications (17), IDE (2), PMA (1) and regulatory petitions for regulation changes or abatement (5). EU regulatory filings include complete CE technical files and CE mark documentation. Quality control plans and regulatory filing information preparation can also be provided as customer needs dictate, in order to support customer generated regulatory efforts.
Interplex Medical meets all of your quality needs by offering a worldwide compliant ISO 13485 medical quality system, whether your needs are components or complete medical devices. The quality system supports FDA and EU design activities and medical device and component manufacturing activities in U.S. FDA and ISO 13485 compliant environments worldwide (Mexico, UK, and US). A uniform, worldwide quality system allows sites to freely exchange projects while maintaining regulatory compliance and meeting customer expectations.
Interplex Medical offers professional consultation and statistical support to meet your requirements in process control, experimental design, analysis of validation data, and Gage R&R. With a degreed statistician and Six Sigma Black Belts on staff worldwide, Interplex Medical offers robust statistical design, analysis and biomedical clinical designs to support regulatory and marketing data requirements. All of Interplex Medical’s sites use SPC, data collection, and analysis tools to provide the latest information on any medical device and/or component manufactured. Interplex Medical Quality staff has authored clinical studies and peered reviewed papers. The staff is able to support multiple statistical methods and tools for data mining and analysis to determine the quality and manufacturability of your medical component and/or medical device.