med_device_photoCeutical Laboratories can become your liaison with the FDA and other world-wide regulatory agencies and assist you from product concept through marketing and distribution.

Ceutical Laboratories has the staff and capability to help you every step of the way.

  • Register your product and facilities with the FDA
  • Provide design control assistance and documentation
  • Provide expert 510(K) and PMA submissions, either in part or in total
  • Track our submissions through the FDA to ensure quick review and timely notification
  • Assist in all regulatory requirements for your submission to assure success through
    • Biocompatibility studies
    • Shipping tests
    • Aging studies/stability studies
    • ISO/ASTM/AAMI tests
    • Product verification studies
    • Product validation studies
  • Ceutical Laboratories manufacturing facilities will ensure complete and thorough technology transfer through process validation and first article inspections to meet your needs and requirements