Overview of regulations for 3D printed medical devices

3D printed medical devices white paperAs 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.

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Within the UL family of companies we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brands, UL is unable to provide consultancy services to Notified Body or MDSAP customers. UL has processes in place to identify and manage any potential conflicts of interest and maintain impartiality. Learn more here.