Medical Software and DiGA Development - Our Blog

Blog articles on topics relevant to medical software, health app and digital health application (DiGA) development.
DiGA revenue & costs: Is a DiGA worthwhile?

DiGA revenue & costs: Is a DiGA worthwhile?

As with any business idea, the financial potential of a DiGA project should be calculated at the outset. A central question arises: Is the development of your DiGA idea worthwhile for you? Potential investors for your DiGA project are also asking themselves this...

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Current DiGA Reports 2024: Official reports at a glance

Current DiGA Reports 2024: Official reports at a glance

Where exactly can I find the latest figures and reports for approved digital health applications (DiGA)? For the strategic planning of new DiGA projects and market analyses, it is important to consider the prescription figures for listed DiGAs. However, when searching...

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DiGA pricing & negotiations with the GKV-Spitzenverband

DiGA pricing & negotiations with the GKV-Spitzenverband

The development of a digital health application (DiGA) costs time and money and involves many regulatory hurdles. As a manufacturer, you naturally have an interest in ensuring that this effort pays off in the end. You probably already know that even if your...

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Interoperability for digital health applications (DiGA)

Interoperability for digital health applications (DiGA)

We would like to quickly introduce the topic of interoperability in DiGA development with a small example: “Μια DiGA πρέπει να πληροί ορισμένες απαιτήσεις διαλειτουργικότητας.” Do you understand this sentence? Unless you speak Greek, probably not. You therefore need...

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Data security & data protection certificates for DiGA

Data security & data protection certificates for DiGA

Status as of 03/14/2024 Digital health applications (DiGA) will soon require certificates for data security and data protection. However, the original deadlines for this were set somewhat too optimistically, which is why they have now been postponed to the future by...

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PECAN & DMD – Guide to DiGA in France

PECAN & DMD – Guide to DiGA in France

What started in Germany at the end of 2019 is now also being adopted by neighboring France: The "app on prescription," the Digital Health Application (DiGA) is becoming an export hit - including a French equivalent to the Fast Track procedure. This provides a uniform...

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Medical devices in Switzerland: MedDO vs. MDR

Medical devices in Switzerland: MedDO vs. MDR

Although Switzerland is geographically located in the heart of the EU, it is not part of it. This also affects manufacturers of (software) medical devices. Is it possible for MDR medical devices to enter the Swiss market without further ado? How do Swiss manufacturers...

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Validation of medical device software according to MDR

Validation of medical device software according to MDR

If you are developing software that qualifies as a medical device under the Medical Device Regulation (MDR), validation is one of the most critical issues. Successful validation of your software is an absolute prerequisite for bringing your medical device to market....

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Requirements of the ISO 13485 – A comprehensive guide

Requirements of the ISO 13485 – A comprehensive guide

Anyone involved in the development of software medical devices is certainly no stranger to the term "Quality management system" (QMS). You may also have heard of ISO 13485 in this context. ISO 13485 is a standard that defines the requirements for a quality management...

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MDR Guide: Clinical evaluation of software medical devices

MDR Guide: Clinical evaluation of software medical devices

"Clinical evaluation? No problem!" "A doctor was recently interviewed in the Süddeutsche Zeitung! She clearly stated that mindfulness apps help with depression. We can refer to that, can't we?" Unfortunately, it's not that simple. Of course, our exaggerated example...

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DiGA: Guidelines for demonstrating positive supply effects

DiGA: Guidelines for demonstrating positive supply effects

 What is the point of a DiGA if it does not improve patients' lives? There is none! This is why DiGAs are only justified when their positive supply effect has been proven. Only then do you have a chance of being permanently included in the BfArM register. Ultimately,...

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Classification of software medical devices: MDR Guideline

Classification of software medical devices: MDR Guideline

"The use of my app is completely safe. It certainly falls into the lowest risk category."- MDR probably sees it differently. Anyone who wants to certify their software as a medical device in accordance with the Medical Device Regulation (MDR) must deal intensively...

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Guide: Is your app a medical device?

Guide: Is your app a medical device?

Status 28.06.2021 That a pacemaker should be a regulated medical device is obvious. However, with software, especially apps, the ambiguity is greater. Mobile apps must also be classified as a regulated medical device if they are used for specific purposes such as the...

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You want to realize a medical software idea?

Contact us without obligation. Together, we will take a look at how much effort would be required and in what time frame implementation would be possible. In addition, we can already provide technical feedback for possible approaches to the development of the software.
QuickBird Medical

QuickBird Studios GmbH
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80335 Munich