Artificial intelligence (AI) in medical devices – MDR guide (2024)
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...
IEC 62304: Software life cycle processes for medical devices
IEC 62304 specifies processes and activities that you must observe when developing software as a medical device. It sets out specific requirements for how you must develop and maintain your software. This applies both to standalone software (e.g., medical apps) and to...
Guide to the DiGAV: Digital Health Applications Ordinance
The Digital Supply Act came into force on December 19, 2019. One of the biggest changes: Digital health applications (DiGA) can now be reimbursed by statutory health insurance companies if they meet certain requirements. To do this, the manufacturer of the healthcare...
Digital Care Act (DVG): Specification of Digital Health Applications (DiGA)
The Digital Care Act for “better care through digitization and innovation” came into force on December 19, 2019. The aim of the Digital Care Act (DVG) is to enable patients to have health applications prescribed by their doctor, make telemedicine more accessible, and...
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