Medical device classification guide

 

Pinpoint your medical device class and your steps to market.

 

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:

 

  • 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