Devices

Medical Devices and In Vitro Diagnostic (Medical) Devices (IVDs)

Our services include, but are not limited to, the following areas in medical devices including IVDs.

  • Global Medical Device and IVD Regulatory Assistance
  • Regulatory Documentation, Preparation, Submission, and Approval/Clearance/Registration (e.g., FDA 510(k)s, PMAs, Pre-IDE, IDE, HDE, and CE Marking) in US and Outside US (OUS)
    • To read about 510(k) contents, go here >>
  • Postmarket Requirements
  • Compliance Activities
  • Risk Management
  • Identifying and Interpreting Guidance Documents (Medical Devices, IVDs, and Radiation-Emitting Products)
  • Identifying and Interpreting Standards (Medical Devices)
  • Identify and Interpret Data Standards (Medical Devices)
  • Device Registration and Listings
  • Medical Device Reporting
  • Importing and Exporting Devices
  • International Regulatory Information (Medical Devices)
  • Unique Device Identification
  • Quality Management Systems (ISO 13485 and 21 CFR Part 820)

To get familiar with medical device software: regulatory and quality requirements

  • Go here to view a list of representative documents useful for consideration for regulatory and quality purposes.

To learn about various devices

  • Click here to learn about Trauma Care devices.
  • Click here to read about Hair Removal devices.
  • Click here to read about Intraocular Lens.
  • Other medical devices that may be of interest to consumers.  Go here >>

To learn about patient safety information

  • As for the Intense Pulsed Light Therapy devices, go here >>

FDA Device Approval Information

  • FDA approves new silicone breast implant
  • No Longer in the Dark: FDA approves the Argus II Retinal Prothesis System
  • Recently-Approved Devices
  • 510(k) Clearances
  • PMA Approvals