Additive manufacturing medical regulations

Validating additive manufacturing processes to meet medical regulations



Ensure safe and reproducible manufacturing results


Manufacturers of products intended for regulated environments, such as the medical industry, are faced with stringent requirements to ensure a high level of quality and safety. For manufacturers of 3D-printed medical devices and other organisations that apply additive manufacturing technologies in the context of the medical industry, these regulatory requirements translate into a strong focus on reproducible and safe manufacturing results.

This whitepaper takes a closer look at requirements related to the qualification, verification and validation of the additive manufacturing processes.

Why download the whitepaper?

  • Understand the principles behind the qualification and validation of manufacturing processes
  • Find out more about current valid standards for additive manufacturing (ISO/ASTM 52920, 52930, 52904 etc.)
  • Use best practice examples to establish quality assured processes for additive manufacturing


Next Steps

Site Selector