Medical device classification guide

Download our medical device classification guide to:

  • Understand what regulatory class your medical device falls under for FDA and EU compliance

  • Determine whether your medical device classes as a hardware or SaMD product

  • Chart your regulatory pathway accordingly

Complete the form to the right to get started!


What you'll get

  1. FDA and EU medical device classification breakdown
    Understand the 7 medical device classification types across the United States and European Union and which your device falls into

  2. Hardware vs. SaMD comparison
    The lines between a hardware and software medical device aren't always clear-cut. Get clarity with our simplified breakdown

  3. Regulatory pathway clarity
    Learn what regulatory requirements your business needs to follow based on your medical device type

Medical device classification guide