High quality and full compliance for a highly specialized market

• Statutory requirements and strict regulations  – both national and international (FDA and ISO 13485)
• High device complexity and small batch sizes
• Strong development and innovation capabilities coupled with fast response times
• Highly automated production processes with numerous manual workstations

The medical technology market is a heterogeneous market characterized by intensive competition and a high level of innovation. At the same time, it demands compliance with stringent quality and safety requirements. That’s why processes have to be optimized for compliance with standards and to prevent errors, while at the same time reducing costs and conserving resources.

Compliance with national and international statutory requirements and regulations, most of which are highly complex, is essential. Europe, for example, has regulations such as ISO 13485 which focuses on risk management through field studies, documentation, traceability and other measures. Since many manufacturers also export their products to the USA, they also have to comply with FDA regulations (FDA cGMP, 21 CFR Part 11 and 820).

The US regulatory authority’s requirements include FDA-conforming system support and detailed documentation of all production-relevant processes and activities so that any medical products which are recalled can be traced back from the customer to the manufacturer.

iTAC solutions for medical technology manufacturing

The iTAC.MES.Suite meets these requirements.  Among other things, the manufacturing execution system satisfies legal requirements of complete production process transparency in real time. Active traceability makes process interlocking possible.

The iTAC.MES.Suite creates a Device Master Record (DMR) for each product containing information about how the product has to be manufactured. The MES also generates an electronic Device History Record (DHR) for every single unit that is manufactured. This eliminates the time-consuming documentation on paper, which is susceptible to errors. At the same time, the iTAC.MES.Suite performs and simplifies quality management. Additionally, it offers the option of completely paperless production on a digital factory basis, including change workflows with digital signatures.

Due to the fact that it is highly standardized, the iTAC MES can replace proprietary solutions. It delivers added value by increasing productivity and hence competitiveness.

The iTAC.MES.Suite enables

• Complete production process transparency in real time
• Higher productivity through optimized production processes
• Defect prevention with process interlocking and preventative strategies
• Paperless production on a digital factory basis
• Release workflows with electronic signatures
• Absolute FDA conformity
• Device history records (DHR)
• Device master records (DMR)

Download iTAC Medical solution