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Validation of medical device software according to MDR

Validation of medical device software according to MDR

by Alexander Fenkiw | Dec 30, 2022 | medical-software-whitepaper, Unkategorisiert

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

Approval certification of software medical devices (MDR)

by Alexander Fenkiw | Mar 31, 2022 | 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

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 2026
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Insider-Empfehlungen für Software-Medizinprodukt-Hersteller in 2026
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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+49 (0) 89 54998380
kontakt@quickbirdmedical.com

 

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13 wichtige Empfehlungen für angehende DiGA-Hersteller 2026

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