Medical Device Directory

FDA Submissions (149 companies found)

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  • mdi Consultants, Inc.

    The Global Regulatory Experts
    FDA Compliance for Medical Devices Companies: Our FDA compliance service line enables you to get your products to market quickly and to maintain your FDA compliance status. As professional consultants to the healthcare industry for over 3 decades, mdi has helped hundreds of companies to achieve and maintain their FDA compliance. What are...
  • Plexus Corp.

    Since 1979, Plexus has been partnering with companies to create the products that build a better world. We are a team of over 19,000, providing global Design and Development, Supply Chain Solutions, New Product Introduction, Manufacturing, and Aftermarket Services. We're an industry leader that...
  • Boyd Corporation

  • RBC Medical Innovations

    RBC Medical Innovations is ISO 13485 | ISO 9001 certified, FDA registered and has been supporting the contract design, development, and manufacturing of medical devices since 1994. We focuses exclusively on designing and producing Class I, II, and III medical devices for US FDA PMA or 510(k) and...
  • McCarthy Consultant Services, Inc.

    As a highly valued regulatory resource to the industry, manufacturers, distributors and importers consistently rely on the quality and timeliness of our regulatory work.
  • Accelerated Advisors

    We help companies navigate through the complex issues of regulatory compliance, quality system and business critical processes and decisions. Quality System development and support for compliance to: FDA QSR 21 CFR 820 and EN ISO 13485:2016 for medical devices Part 110 and Part 111 for...
  • Trob 32 Incorporated

    Serving the medical device and life sciences for compliance and technical global deployments.
  • FOI Services Inc.

    FOI Services provides access to millions of pages of unpublished US Food and Drug Administration documentation acquired under the Freedom of Information Act. Available FDA files cover the full range of FDA authority, including the approval and regulation of pharmaceuticals, medical devices and...
  • RND Group Inc. The

    The RND Group has worked with the leading companies in the medical device industry since 1997. The RND Group fully understands the rigor required in designing, developing, documenting, and testing software/products that are regulated by the FDA. The RND Group has applied that rigor to the...
  • Gold's Associates LLC