QBit QA Consulting
Broomfield, CO
763-567-8783

Medical Device Development

QBit QA Consulting offers comprehensive consulting services to support the development of medical devices, from initial concept through to commercialization. QBit QA brings a wealth of experience in navigating the complex regulatory requirements, industry standards, and technological innovations that are essential for bringing safe, effective, and market-ready devices to patients worldwide.

DEVICE DEVELOPMENT PROCESS

  • Device Discovery and Concept – Research for a new device begins in the laboratory.
  • Preclinical Research / Prototype – Devices undergo laboratory and animal testing to answer basic questions about safety.
  • Pathway to Approval – Devices are tested on people to make sure they are safe and effective.
  • FDA Review – FDA review teams thoroughly examine all of the submitted data related to the device and make a decision to approve or not to approve.
  • FDA Post-Market Safety Monitoring – FDA monitors all device safety once products are available for use by the public.

Medical Device Classification

Class I (low to moderate risk): general controls
Class II (moderate to high risk): general controls and special controls
Class III (high risk): general controls and Premarket Approval (PMA)

General Controls
  • 501: Adulterated devices
  • 502: Misbranded devices
  • 510: Registration of producers of devices
    • Establishment registration and device listing
    • Premarket Notification (510k)
    • Reprocessed single-use devices
  • 516: Banned devices
  • 518: Notifications and other remedies
    • Notification
    • Repair
    • Replacement
    • Refund
    • Reimbursement
    • Mandatory recall
  • 519: Records and reports on devices
    • Adverse event report
    • Device tracking
    • Unique device identification system
    • Reports of removals and corrections
  • 520: General provisions respecting control of devices intended for human use
    • Custom device
    • Restricted device
    • Good manufacturing practice requirements
    • Exemptions for devices for investigational use
    • Transitional provisions for devices considered as new drugs
    • Humanitarian device exemption
Special Controls
  • Performance standards
  • Postmarket surveillance
  • Patient registries
  • Special labeling requirements
  • Premarket data requirements
  • Guidelines

LINKS

FDA