Medical technology

• Legal requirements and strict regulations from the American regulatory body FDA
• Highly sophisticated machines
• Highly automatic processes on the one hand, many manual work places on the other.

Owing to the fact that failures during production processes can have particularly serious consequences in the medical technology sector, quality assurance and compliance with standards and specifications play an especially important role.

The complex legal requirements and regulations from the American regulatory board FDA (FDA cGMP, 21 CFR Part 11 and 820) are among the most challenging. In the written stipulations, FDA-conform system support is required as well as detailed documentation of all production-relevant processes and requirements so that the medical product can be traced from the manufacturer to the customer in the case of recall campaigns.

iTAC solutions for the challenges faced in the medical technology sector
The high standardization of software enables systematic quality management – optimized processes and an increase in productivity are the positive results for the company.

The iTAC.MES.Suite enables

• completely transparent manufacturing processes in real time.
• an increase in productivity through optimized production processes.
• failure avoidance in advance through interlocking and prevention strategies.
• paperless completion of a “digital factory”.
• release workflows with electronic signatures.
• total FDA conformity.

Application examples

• Siemens Med COM Case Study