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Medical Devices (Class I, Class II, Class III)

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FDA Application and GMP/QSR Consulting

Medical Devices (Class I, Class II, Class III)

  • Class I: General Controls, with or without Exemptions
  • Class II: General Controls and Special Controls, with or without Exemptions
  • Class III: General Controls and Premarket Approval

Services

BBC Training

Released FDA application training and GMP/QSR training courses on medical devices: