Malte Bucksch, Author at QuickBird Medical

Approving software medical devices without quality management and regulatory requirements?

by Malte Bucksch | Jan 8, 2025 | medical-software-whitepaper

The Medical Device Regulation (MDR) poses many challenges for manufacturers of software medical devices. In addition to establishing a quality management system (QMS) and preparing technical documentation, manufacturers face regulatory liability risks. For many...

DiGAV and DVG: Important Links

by Malte Bucksch | Mar 17, 2024 | diga-whitepaper, Unkategorisiert

Here you will find the most important links to the Digital Healthcare Act (DVG) and the Digital Health Applications Ordinance (DiGAV). This list is intended to help you access the relevant documents more quickly for regular reference. This page also provides an...

Artificial intelligence (AI) in medical devices – MDR guide (2026)

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...

Guide to the DiGAV: Digital Health Applications Ordinance

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

The Digital Healthcare Act (DVG) came into force on December 19, 2019. One of the biggest changes: Digital health applications (DiGA) can now be reimbursed by statutory health insurance funds if they meet certain requirements. To do this, the manufacturer of the...

Digital Care Act (DVG): Specification of Digital Health Applications (DiGA)

by Malte Bucksch | Jan 15, 2020 | Unkategorisiert

The Digital Healthcare Act (DVG) for “better care through digitization and innovation” (translated from German) came into force on December 19, 2019. The aim of the DVG is to enable patients to have health applications prescribed by their doctor, make telemedicine...