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DiGA: Guidelines for demonstrating positive supply effects

DiGA: Guidelines for demonstrating positive supply effects

by Alexander Fenkiw | Nov 25, 2025 | diga-whitepaper, Unkategorisiert

 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....
Certification of digital courses according to ZPP – Central Prevention Testing Center

Certification of digital courses according to ZPP – Central Prevention Testing Center

by author1 | Oct 16, 2025 | Unkategorisiert

Those who develop digital offerings for health promotion or prevention often face the question: How can these be financed through health insurance companies? Many software manufacturers are familiar with the reimbursement options available through DiGA. Much less well...
Switzerland: Reimbursement for digital health applications (DiGA & dGA)

Switzerland: Reimbursement for digital health applications (DiGA & dGA)

by Sabine | May 15, 2025 | diga-whitepaper, Unkategorisiert

In 2020, Germany became the first country to establish DiGA in regular healthcare. This means that digital health applications can be approved in a structured, transparent process. Once approved, DiGA can then be prescribed by doctors in a similar way to medication....
All insights: Development and approval of software medical devices in 2025

All insights: Development and approval of software medical devices in 2025

by Daniel Lange | Feb 5, 2025 | medical-software-whitepaper, Unkategorisiert

Over the past ten years, we have learned a great deal about the development of software medical devices. We are pleased to share this expertise in our technical articles with (prospective) developers of Software as a Medical Device (SaMD) so that not everyone has to...
MDR Risk Class I vs. IIa: Differences for software medical devices

MDR Risk Class I vs. IIa: Differences for software medical devices

by Alexander Fenkiw | Jan 9, 2025 | medical-software-whitepaper, Unkategorisiert

At the beginning of the development of a software medical device, the central question is: Which risk class applies to my product? Risk classification has serious implications and significantly influences the cost and time frame of product development. In extreme...
DiPA guide: digital applications for care

DiPA guide: digital applications for care

by Alexander Fenkiw | Sep 18, 2024 | Unkategorisiert

On December 19, 2019, the Digital Care Act (DVG) made it possiblethat doctors can now prescribe digital health applications (DiGA) to patients in a standardized way for the first time. A counterpart to this has also been created for nursing care: digital care...
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Insider-Empfehlungen für DiGA-Hersteller in 2025
Downloaden Sie jetzt unser Whitepaper

Insider-Empfehlungen für Software-Medizinprodukt-Hersteller in 2025
Downloaden Sie jetzt unser Whitepaper


Sie planen eine Medical Software oder DiGA?

Sprechen Sie mit unserem Geschäftsführer Malte Bucksch

+49 (0) 89 54998380
kontakt@quickbirdmedical.com

Are you planning to develop medical software or a digital health application?

Speak with our managing director, Malte Bucksch

+49 (0) 89 54998380
contact@quickbirdmedical.com
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13 wichtige Empfehlungen für angehende DiGA-Hersteller 2025

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