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 places specific requirements on how you must develop and maintain your software. This applies both to stand-alone software (e.g. medical apps) and to...
Interoperability in medicine: Explained using simple examples
A large number of electronic devices are used in medicine, and medical apps are now also increasingly being used. However, a major problem to date is that many of these devices cannot “talk” to each other: Exchanging data is often difficult or impossible. In this...
Guide to the DiGAV: Digital Health Applications Ordinance
Status as of April 19, 2021 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...
Digital Supply Act (DVG): Implications for App Manufacturers
As of April 19, 2021 The Digital Care Act for “better care through digitalization and innovation” came into force on December 19, 2019. The aim of the so-called “Digital Care Act” (DVG): Patients will be allowed to have healthcare applications prescribed by their...
Guideline for the development of medical apps: What manufacturers need to look out for
As of 06/28/2021, by Malte Bucksch 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...
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