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Guide: Is your app a medical device?

Guide: Is your app a medical device?

by Malte Bucksch | Sep 10, 2024 | 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...
Artificial intelligence (AI) in medical devices – MDR guide (2024)

Artificial intelligence (AI) in medical devices – MDR guide (2024)

by Malte Bucksch | Feb 22, 2024 | medical-software-whitepaper

With ChatGPT at the latest, artificial intelligence (AI) has become the topic of our time – also in the field of software medical devices. Many manufacturers are unsure about the extent to which AI can be used in medical devices at all. For this reason, in this...
Requirements of the ISO 13485 – A comprehensive guide

Requirements of the ISO 13485 – A comprehensive guide

by Alexander Fenkiw | Nov 10, 2022 | medical-software-whitepaper, Unkategorisiert

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...
Approval & certification of software medical devices (MDR)

Approval & certification of software medical devices (MDR)

by Alexander Fenkiw | Mar 31, 2022 | medical-software-whitepaper, medical-software-whitepaper

How does medical device approval for software work? How long does this process take? And what are the costs involved in certification? The path to medical device approval is also complex for software products. It is therefore advisable to deal with the...
Guideline for the development of medical apps: What manufacturers need to look out for

Guideline for the development of medical apps: What manufacturers need to look out for

by Malte Bucksch | Jan 16, 2019 | medical-software-whitepaper, Unkategorisiert

Medical apps are now being used more and more frequently, e.g. in disease prevention, disease diagnostics, disease treatment or for the monitoring of vital parameters. However, it is not that easy to launch a medical app on the market that is secure and compliant with...
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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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13 wichtige Empfehlungen für angehende DiGA-Hersteller 2025

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