Designing and Establishing a Quality System for the Development and Manufacture of a Medicated Device

  • Background: anatomy, technical requirements, standards, compendial and regulatory requirements for a variety of medicated devices (viz., drug-coated stents, -catheters, -implants, -electrode leads) and systems; how they work, how are they used how they are regulated
  • Evolution and current state of quality system regulatory requirements pertaining to medicated devices and systems; applicability
  • CGMP, QSR, GTP, and other quality related FDA regulations
  • Device design controls, design validation, human factors
  • Applicable quality related standards
  • Collaborative development of drug delivery devices and systems, development and purchasing relationships, requirements and vendor controls
  • Streamlined, linked and isolated quality systems
  • Compliance and inspections