Development of the 3D-printing environment in Pohjois-Savo, investment & research projects, 1.10.2019 - 31.12.2020
This page publishes procurement-related questions and answers.
Procurement: "Ohjelmisto 3D-tulostukseen"
Link to the reques for quotation in Hilma: https://www.hankintailmoitukset.fi/fi/public/procurement/41665/notice/55180/overview
Two questions, with their answers can be found below:
Question 1: Does the Order accept the software for 3D printing with only CE approved for making anatomical 3D prints for diagnostic use? (In section 3. Object of the acquisition, the Orderer requires: "The program offered must be CE approved and must be FDA approved for making anatomical 3D prints for diagnostic use."
- Answer: Yes, the software for 3D-printed anatomical models should have both CE and FDA approval. There is a possibility of research cooperation, and we want a software that is usable in both USA and in EU.
Question 2: We would like ask for clarification, about what kind of certification is required by the Orderer to fulfill this requirement? (In section 3. Object of the acquisition the Orderer requires: "The software manufacturer must be certified to use the software for healthcare applications for two or more of the following 3D printers used by Savonia: Stratasys J735 / J750, Formlabs Form 2+, Ultimaker S5, HP MJF 580.")
- Answer: A certification provided by the software provider, meaning that the software provider has done comprehensive testing with the 3D-printer and specific material. Software provider guarantees that using their software will produce accurate anatomical models when using the certified 3D-printer (and material) according to the technical instructions from the machine manufacturer.