Accumedix provides complete services to develop your ideas into innovative medical devices. Our Accumedix facility (Grayslake, IL) is FDA registered and has obtained ISO 9001, ISO 13485 certifications for European Notified Body, DQS, Medical Device Directive and FDA Quality System Reg. 21 CFR Part 820. Accumedix customers range from individual inventors to fortune 100 companies

Accumedix also provides consulting expertise to its customers on product design, development and manufacturing regulatory compliance through its partnership with Vantage Consulting

What We Do:
Product Design and Regulatory Submission Assistance

    * Design for cost and manufacturability
    * Packaging design
    * 510K and other regulatory submissions and device listings
    * Regulatory facility registrations
    * Regulatory consulting services

Process Development
    * Manufacturing and assembly procedures
    * Testing procedures
    * Design control processes
    * Equipment validations including IQ, OQ and PQ
    * Validation protocol development, testing and final reports
    * Packaging testing
    * Sterilization validation

Material Procurement and Control
    * Vendor selection, audit and approval
    * Inventory management
    * Raw material and component purchasing
    * Incoming receiving and inspection
    * Warehousing with full lot control

Manufacturing and Assembly
    * Clean room and non-clean room manufacturing
    * Clinical trial through full production scale
    * Full lot control and/or serialization
    * In-process and final quality assurance

Packaging and Sterilization
    * Sterile packaging
    * Sterilization coordination

Quality Management
    * Device master record/Device history record
    * Act as management representative to FDA and other regulatory agencies
    * Device manufacturing documentation
    * Work order history
    * Full lot control
    * Quality consulting services

Accumedix, Inc.

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