Malte Bucksch, Author at QuickBird Medical

IEC 62304: Software life cycle processes for medical devices

by Malte Bucksch | Sep 17, 2020 | Unkategorisiert

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...

Guide to the DiGAV: Digital Health Applications Ordinance

by Malte Bucksch | Mar 31, 2020 | diga-whitepaper, Unkategorisiert

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 Supply Act (DVG): Implications for App Manufacturers

by Malte Bucksch | Jan 15, 2020 | diga-whitepaper, Unkategorisiert

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 doctor, telemedicine will...

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...