Since the new regulations for Medical Devices and In-vitro-Diagnotics are approved the innovation, industrialization, transfer and manufacturing of medical devices is more complex than ever. Especially the development process according to the ISO13485 shall be extreme efficient to save costs and time to market without any compromises in regulator and clinical issues.
Regarding parts made of polymers, such as PP, COC or PEEK, manufactured by injection molding,
the focus is today on sustainable material solutions, smart manufacturing solutions incl. risk based approaches to qualify equipment and validate/re-validate processes.
Key to fulfill these requirements are experienced project manager, toolmakers and equipment manufactures with “medical” background, well designed processes and a reasonable budget and project timeline, to have a good project setup and to execute the different project phases incl. market launch.
For more information to the project and
the different services please contact:
Dipl.-Ing, (FH), Wirt.-Ing. (FH), QMB | Managing Director
Tel. 0176 787 451 29