MANUFACTURING
SERVICES
PILOT BUILDS
CLASS 100.000
ECR ASSEMBLY
DESIGN FOR MANUFACTURING
SIX SIGMA & LEAN METHODOLOGY
CONTRACT
PACKAGING
INVENTORY
MANAGEMENT
ENGINEERING
PROJECT
MANAGEMENT
ENGINEERING
& DESIGN
BREADBOARDS
& PROTOTYPES
CLINICAL
TISSUE LABS
RESEARCH
& DEVELOPMENT
PRODUCT
DEVELOPMENT
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Interplex Medical Quality Systems are established to comply with U.S. FDA requirements, ISO 13485:2003. Quality standards have been met by highly trained personnel with extensive U.S. and EU regulatory experience who have successfully filed for 501(k) applications. Quality control plans and regulatory filing information preparation can also be provided as customer needs dictate. Regulatory petitions for regulation changes or abatement (5). EU regulatory filings include complete CE technical files and CE mark documentation. If your needs are components or complete medical devices, Interplex Medical offers a worldwide compliant ISO 13485 medical quality system. The quality system is FDA registered and it supports EU design activities and medical device component manufacturing. A uniform worldwide quality system allows sites to freely exchange projects while maintaining regulatory compliance. Quality at Interplex Medical meets customer expectations.
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 registered device manufacturing 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 peer 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.
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