Medical device classification PDF guide


Pinpoint your medical device class and your steps to market.


Download our medical device classification PDF 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:


  • Subttasks-bgFDA 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

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

  • Target-bgRegulatory pathway clarity
Learn what regulatory requirements your business needs to follow based on your medical device type