AM in a Certified Environment under DIN SPEC 17071

SAMAPLAST AG has been certified in accordance with DIN SPEC 17071 for additive manufacturing (AM) since November 2020 and/or in accordance with ISO ASTM 52920 during the course of 2021.

With this AM certification, SAMAPLAST AG fulfils the following TÜV SÜD inspection criteria for third parties:

• Quality management for AM processes
• Service competence for consulting and production
• Quality assurance for industrial and medical applications
• Reproducible and traceable processes
• Controlled material qualification/validation
• DIN SPEC 17071 implemented

With this AM certification and EN ISO 13485 and/or registrations and permits, from the FDA, ANVISA and JPAL, SAMAPLAST is in a position to fulfil the critical requirements and crunch points in AM manufacturing for the medical technology/implant market.

Manufacturing from the initial idea to packaged medical product or implant made from high-end plastics such as PLA, PEEK, TPU and PCU in a controlled environment (ISO 8 in operation), on qualified 3D printers and freeformers, and in a holistically functional, valid environment/system built on a risk-based approach can be implemented smoothly together with the customer.