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Class I Software according to MDR – is that still possible? (September 2025)

Class I Software according to MDR – is that still possible? (September 2025)

by Alexander Fenkiw | Sep 27, 2025 | medical-software-whitepaper

Are there still Class I software medical devices according to MDR? Are regulatory authorities really withdrawing Class I software products from the market in droves? Which federal state do I need to go to in order to remain on the market with my Class I software? As...
Classification of software medical devices: MDR Guideline

Classification of software medical devices: MDR Guideline

by Alexander Fenkiw | Sep 27, 2025 | medical-software-whitepaper

“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...
Guide: Is your app a medical device?

Guide: Is your app a medical device?

by Malte Bucksch | Sep 27, 2025 | medical-software-whitepaper

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 diagnosis or...
Innovation Fund (2025): Funding for digital health solutions

Innovation Fund (2025): Funding for digital health solutions

by Daniel Lange | Jun 13, 2025 | medical-software-whitepaper

Many manufacturers of medical software and health apps are faced with the question: How can digital solutions be used to build a sustainable business model? The market for self-paying patients in the German healthcare system is relatively small, and the path to...
AI Act: Guidelines for medical device manufacturers according to MDR (2025)

AI Act: Guidelines for medical device manufacturers according to MDR (2025)

by Alexander Fenkiw | Jan 31, 2025 | medical-software-whitepaper

The EU is now also regulating the use of artificial intelligence (AI) with the EU AI Act. This also affects manufacturers of software medical devices that integrate AI into their MDR medical devices. The AI Act is intended to ensure that AI systems are designed in a...
Approving software medical devices without quality management and regulatory requirements?

Approving software medical devices without quality management and regulatory requirements?

by Malte Bucksch | Jan 8, 2025 | medical-software-whitepaper

The Medical Device Regulation (MDR) poses many challenges for manufacturers of software medical devices. In addition to establishing a quality management system (QMS) and preparing technical documentation, manufacturers face regulatory liability risks. For many...
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Insider-Empfehlungen für DiGA-Hersteller in 2025
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Insider-Empfehlungen für Software-Medizinprodukt-Hersteller in 2025
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Sie planen eine Medical Software oder DiGA?

Sprechen Sie mit unserem Geschäftsführer Malte Bucksch

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

 

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