Medical Device Directory

FDA Submissions (143 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...
  • Paladin Medical Inc.

    Submissions: FDA Regulatory Pathways and Submission Types Some of the pathways to market you may not have heard much about. Special 510(K) Traditional 510(k) Abbreviated 510(k) PMA and PMA supplements HDE/HUD De Novo Combination Product – Read more in SPECIALTY SERVICES Investigational Device studies may...
  • Language Scientific Inc.

    Scientific, Technical, and Medical Translation Services.
  • PAREXEL International Corporation

  • Medical Equipment Compliance Associates

    MECA was formed in 2002, to assist medical device companies with safety certification, ISO 17025 accredited compliance reports, and regulatory needs. We have grown our business and our network of associates with the leaders in their respective fields, to offer the highest level of certification...
  • Optim Associates, Inc.

    OPTIM Associates is a Medical Device consulting company specializing in Quality Systems design, development, execution and remediation for newly developed products as well as existing fielded products. Our specialty runs the entire spectrum from Start-Up QS & 510(k) to QS Remediation assistance...
  • Cirtec Medical

    Cirtec Medical is a vertically integrated, full-service outsource partner providing end-to-end product design, development and manufacturing of complex medical devices and components. We specialize in today’s most advanced product technologies, including neuromodulation, implantable drug...
  • The Realtime Group

    The Realtime Group is a software and electronics design and validation testing firm with small business diversity yet certified to ISO13485:2003 for providing software validation, independent verification and validation, and design solutions related to government IT, medical devices, wireless...
  • Akron Rubber Development Laboratory, Inc.

    Akron Rubber Development Laboratory, Inc. (ARDL) is an ISO 9001:2015 registered, A2LA accredited to ISO 17025:2017, ISO 13485:2016 compliant, independent testing, development and problem-solving laboratory for all facets of the plastics, rubber and latex industries. ARDL has the resources and...
  • Lighthouse Imaging Corporation

    Lighthouse Imaging Corporation develops and manufactures optical imaging solutions for the medical device industry. We specialize in endoscopic imaging systems, endoscope test equipment, and video coupling optics. We excel in micro-video optical systems. Lighthouse Imaging is an ISO 9001/13485...