We use cookies, similar technologies and tracking services

This website uses cookies, similar technologies and tracking services (hereinafter referred to as “Cookies”). We need your consent for Cookies, which not only serve to technically display our website, but also to enable the best possible use of our website and to improve it based on your user behavior, or to present content and marketing aligned with your interests. For these purposes, we cooperate with third-party providers (e.g. Salesforce, LinkedIn, Google, Microsoft, Piwik PRO). Through these partners you can also receive advertisements on other websites.
If you consent, you also accept certain subsequent processing of your personal data (e.g. storage of your IP address in profiles) and that our partners may transfer your data to the United States and, if applicable, to further countries. Such transfer involves the risk that authorities may access the data and that your rights may not be enforceable. Please select which Cookies we may use under ”Settings”. More information, particularly about your rights, e.g. to withdraw consent, is available in our Privacy Policy .


Only technically necessary Cookies

Accept everything

Below, you can activate/deactivate the individual technologies that are used on this website.

Accept All


These Cookies make a website usable by providing basic functions such as page navigation, language settings, Cookie preferences and access to protected areas of the website. Cookies in this category additionally ensure that the website complies with the applicable legal requirements and security standards. Owing to the essential nature of these Cookies, you cannot prevent their use on our website. Details about these Cookies are available under 'More information'.

Functionality and personalization

These Cookies collect information about your habits when using our web pages and help us to enhance your user experience by tailoring the functions and attractiveness of our web pages based on your previous visits, location and browser settings. They also enable access to integrated third-party tools on our website (e.g., Microsoft Azure for single sign-on authentication). This can involve transferring your data to the United States (for information on the risks involved read Clause 1.5 of our Privacy Policy). If you refuse these Cookies, you might not be able to access the full functionality of the website. Details about the tools we use are available under 'More information'.


These Cookies are used to compile basic usage and user statistics based on how our web pages are used (e.g. via Google Tag Manager, Piwik PRO). If you accept these Cookies, you simultaneously consent to your data being processed and transmitted to the United States by services such as Salesforce Pardot (for information on the risks involved read Clause 1.5 of our Privacy Policy). Details about the tools we use are available under 'More information'.

Marketing and social media

These Cookies help third-party sources collect information about how you share content from our website on social media or provide analytical data about your user behavior when you move between social media platforms or between our social media campaigns and our web pages (e.g., LinkedIn Insights). Marketing Cookies from third-party sources also help us measure the effectiveness of our advertising on other websites (e.g. Google Ads, Microsoft Advertising). We use these Cookies to optimize how we deliver our content to you. The third-party sources and social media platforms we use can transfer your data to the United States (for information on the risks involved read Clause 1.5 of our Privacy Policy). If you accept these Cookies, you simultaneously consent to your data being transferred and processed as described above. Details about the tools we use and our social media presence are available under 'More information'.

More information

Save Settings

Quality assurance in MedTech companies with MES/MOM solution from iTAC

Making all procedures and changes in the production process paperless and traceable with a production-related IT solution

Montabaur, June 1, 2022 – In medical engineering, extraordinarily high demands are placed on quality and strict regulations apply. In addition, the demand for medical products is rising steadily, due in part to the Covid 19 pandemic. As a result, manufacturing processes are under time pressure, which can affect the defect rate of products and have serious consequences. Quality management (QM) in MedTech companies therefore plays a major role. By using a production-related IT solution, i.e., an MES or MOM, the requirements for complete documentation and traceability can be met reliably and in compliance with guidelines. iTAC Software AG supports these tasks with the iTAC.MOM.Suite.

"The production of medical products is governed by strict regulations and requirements. In addition, the new Medical Device Regulation (MDR), which became effective in Europe in 2021, imposes even higher standards for the QM system of medical technology companies and increases the pressure. This requires appropriate strategies and solutions on the manufacturer side in order to be able to withstand the increasing regulatory requirements in the market and to compete effectively," explains Martin Heinz, management board of iTAC Software AG.

Compliance: Manufacturing according to regulations

MES/MOM solutions reliably support seamless documentation and traceability in medical technology production and ensure compliance with regulatory guidelines. For example, processes such as the installation of components with serial numbers or the use of test equipment during production must be documented in detail and the corresponding requirements must be met.

"Without a supporting MES, all steps in the production of a medical device are processed and documented on paper. In the production of blood analysis instruments, for example, each work step and each component must be recorded on paper documents, which are then integrated into a manual and time-consuming approval process. If the test requires any necessary rework, this also must be documented manually again and all documents have to be archived afterwards, which can delay the entire manufacturing process by weeks," explains Martin Heinz.

The iTAC.MOM.Suite is a holistic manufacturing management system that provides all the necessary features for digital worker management, process automation and traceability of serialized products in a validated manner. The MES/MOM solution is used in production facilities in the pharmaceutical and medical industries to meet the specific requirements of international and national standards and guidelines and to guarantee the market a flawless, safe product.

With features such as material management including setup control, process interlocking, tool and test equipment management – embedded in a worker management system – the iTAC.MOM.Suite ensures that production only conforms to specifications and that all specified work and test steps are actually carried out. This reduces the time and effort required for approval processes, subsequent assembly and repairs.

Identify and eliminate quality problems in real time

"With Active Traceability, our MES/MOM solution ensures that quality problems in the production processes can be detected in real time, causes can be analyzed and corrective measures can be systematically and promptly evaluated in a continuous improvement process. All production information is made available to the worker in the process in real time. In addition, this data is provided in different levels of aggregation to various functional areas of a company – even up to the management level.

In the event of a callback, the product, including batch and serial numbers, can be traced back from the manufacturer to the customer. What is considered a standard function in the iTAC.MOM.Suite represents a decisive competitive function for medical manufacturing companies," explains Martin Heinz.