Overview of regulations for 3D printed medical devices

Medical device regulations for 3D printed devices

Questions? Request more information from our specialists


As 3D printing techniques have matured, and the industry has improved printing quality and efficiency, 3D printing technology has rapidly spread into many industries, including the medical device and tissue engineering industries.

However, if you are marketing a 3D printed device, there are some important regulatory considerations you need to know about. In this 6-page white paper, we discuss the biggest concerns for 3D printed devices, including:

  • regulatory challenges
  • interpreting regulatory guidance
  • materials qualification, software validation, and process validation
  • finished product testing
  • the future of 3D printing
  • and much more.