June 22, 2021 1 min read
A validated workflow is a complete process, start-to-finish, for consistently producing safe parts that are compliant with the stringent standards that are set for medical devices. Validated workflows are more than just printing parameters.
A common myth is that if aresin is biocompatible in a liquid state, then it is suitable for producing medical devices. However, this couldn’t be further from the truth.
Resins in a liquid state are highly hazardous to human health and the environment as shown in their respective MSDS. However, if cured correctly as shown in the instructions for use (IFU) by the manufacturer and with the correct printing parameters and post processing protocol, they are able
Therefore, the following steps are required for a validated workflow:
Typical FDA and CE regulatory bodies in the US and EU respectively have defined safety standards for 3D printing resins and therefore the workflow requirements. A validated workflow is then an assurance to the user of the printer and the resin being safe and compliant with regulations.