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Perhaps you have already learned from our blog that we want to get certified according to ISO 13485. ISO 13485 is a standard for requirements of the quality management system, specifically for the development of medical products. It serves to ensure the product, as well as the safety of the patient and the user. But this is just a small refresher. This blog article is about the IEC 62304. What is IEC 62304? IEC stands for International Electrotechnical Commission. The IEC 62304 is therefore a collection of proven practices for the development of medical software established by this Commission.It is...

The year 2020 did not go so well for many. Therefore, we hope to leave the bad spirits behind and celebrate the beginning of the new year! Of course, the world is not suddenly different on 1.1.2021, but there is hope that normality will return to everyday life over the course of the year. Even if New Year's Eve is celebrated this year on a smaller and much quieter scale, one can set goals for the new year, organize one's thoughts, and start the new year prepared this time. That's the advantage the new year brings. At the beginning of...

  Christmas will be different this year than most people know it. Due to the pandemic and the definitely necessary social distancing rules, households can only meet with four other people over the age of 14 during the Christmas holidays, outside of the holidays, groups of people are also limited to five people from a maximum of two households in the private sector. These regulations naturally cause discontent among the majority of the population. After all, we have been dealing with the pandemic all year round. Some more than others, but no one has been completely spared from the circumstances....

It's no secret that online retail is becoming increasingly prevalent, replacing active shopping in stores. This phenomenon particularly affects individual retailers. While walk-in customers are not absent, the proportion of actively buying customers is continually decreasing. Retail is increasingly becoming a tourist attraction, the "last-minute stop" for gifts, or simply a leisure activity. The incentive to go out and buy something that can be obtained much more conveniently on the internet is simply no longer there. Because ordering on the internet is time-saving, offers a wider selection, and most importantly, you know immediately whether something is still available or not.This...

In the current situation, the employees' requests for home office options are becoming louder. The Federal Office for Civil Protection and Disaster Assistance (BBK) also recommended creating home office options as early as April of this year (BBK action recommendation). However, this poses a surprisingly large challenge for many companies. In order to send employees to the home office, certain conditions must be met: The employee must be provided with the technical means to be able to accomplish all tasks. The employee must have full access to all work-relevant data and systems.There must be simple communication options for internal and...

In our constant effort to improve, we are pleased to announce that we are well on our way to having ourselves and thus our quality management system certified according to ISO 13485. This expands our portfolio in software development to include the field of medical devices. As an ISO 13485 certified company, we can ensure that our software does not pose an obstacle to obtaining approval or certification for your medical devices.   But what exactly is ISO 13485 and why is it so important for the medical device industry? ISO 13485 is a standard that sets requirements for the...