FDA

510K & FDA Compliance

Banner Medical can help medical device OEMs achieve FDA 510K approval and maintain full compliance throughout the development of an implant or instrument product launch. Our professional staff has been involved in numerous device and instrument launches and has the knowledge, experience and expertise required to speed up the product realization process. Our areas of expertise include:

  • Device Registration
  • QMS Compliance
  • Regulatory Compliance
  • Documentation/Traceability
  • IQ, OQ, PQ Process Validation

Contact Banner Medical to learn more about our consultation services today!