BSI TR-03161 for DiGA – Implementation & Consulting

Anna-Lena Hudalla
Managing Director of the Digital Women's Health Institute

"We developed the software for the mamly app with QuickBird Medical and also had it certified as a medical device. The app turned out great and was explicitly highlighted as outstanding in the IT Security Pen Test. QuickBird Medical was a reliable partner throughout the entire project and mamly is now going live ahead of schedule! QuickBird Medical was also indispensable when it came to regulatory issues, MDR and data protection. A great, uncomplicated, interdisciplinary and professional team. We are already planning further development and will also want to implement new projects with QuickBird Medical. Many thanks to the whole team!"

Dr. Andreas Sprock
CEO of MiNDNET E-Health AG

„You keep hearing about companies that develop their medical device software three times. The first time they just go for it, the second time with a service provider who claims to be able to develop medical device software and then the third time with a company that has done this before. We were very lucky to come across QuickBird Medical. The team around Malte and Stefan knows what it means to develop medical device software that fulfills all regulatory requirements and can also be approved as a DiGA. Together with the highly motivated team, we were able to realize ORIKO in record time: a visually, technically and medically high-quality app that achieves measurable medical effects. I can therefore recommend QuickBird Medical with a clear conscience.“

Dr. med. Andreas Lechner
Head of the Diabetes Research Group at LMU Munich

"Working with QuickBird Medical was a pleasure in every respect. The quality of the software and the easy and effective communication with each other was excellent."

Roman Schenk
Managing Director & Board Member of Recardio Inc.

„QuickBird Medical developed the digital platform CardioCare with us and assisted us with medical device certification in accordance with the MDR. Malte and Stefan's team implemented the functionality of the medical device software and created the technical documentation in accordance with ISO 13485 and IEC 62304. Their commitment played a decisive role in ensuring that CardioCare meets all the regulatory requirements of the MDR. The product can be connected to multiple FDA-approved wearable sensors, enabling the collection of digital biomarkers in clinical trials. We are extremely pleased with the result and look forward to a continued successful collaboration.“

Annerose Berweck
Managing Director of Child&Brain

"We train doctors all over the world to treat muscular dysfunctions. We wanted an app to teach the medical content. QuickBird Medical developed a state-of-the-art and reliable app for us, which we now use in every workshop."

Anke Mayfarth
Managing Director and Co-Founder of tediro GmbH

„QuickBird Medical has developed the therapy planning platform for our THERY therapy robot. Thanks to QuickBird's software and regulatory expertise, the product was successfully implemented in accordance with IEC 62304 as part of our medical device. The platform can now be used in a pilot phase in various clinics. The collaboration went really well. QuickBird Medical knows how to develop reliable and user-friendly web applications - in a regulatory environment.“

Dr. med. Andreas Ziegler
Senior Physician in Neuropaediatrics & Metabolic Medicine at Heidelberg University Hospital

„The telemedicine platform developed by QuickBird Medical has proven to be a very good solution for connecting HIS systems and other health data sources. Particularly noteworthy is the user-friendliness of the platform, which enables complex medical data to be managed efficiently and the exchange between patient and treatment centers to be seamless. We appreciate the constructive cooperation with the QuickBird team and see this partnership as a key factor in our success in implementing the project.”

Astrid Elsenhuber
Practical advice and sales at Labor Becker

„QuickBird Medical combines in-depth technical expertise with extensive knowledge of the healthcare sector. The team developed an app for us that addresses pregnant women with an empathetic approach across all touchpoints. The result is a stable and visually appealing product that our users enjoy using every day. The great personal commitment of all QuickBird employees is particularly noticeable in the result."

Paul-Lukas Good
President of Swiss Cannabis Research

"The collaboration with QuickBird Medical could not have gone better. We were particularly impressed by the conceptual input and creative thinking of the entire team—especially with regard to the extremely high requirements for data security and data protection. At every stage of the process, ideas for optimizing our study platform were proactively proposed and implemented. The support after go-live is also first-class – we can always rely on the QuickBird team for fast, competent help. We are completely satisfied and look forward to further joint projects!"

Laura Henrich
CEO of Klenico

"QuickBird Medical understands down to the smallest detail how to develop and safely operate regulated medical device software, even in higher risk classes of the MDR. The team manages a complex software landscape of web and backend components for us and ensures that everything runs smoothly and is always compliant with regulations. We have also benefited enormously from their expertise in the area of cyber security. We feel we are in very good hands in every respect."

Bernhard Schlichtner
Managing Partner of Combyn Healthcare

"QuickBird Medical developed the embedded software for our medical device. The entire project process—from the initial discussions to the first release-ready version—was implemented excellently. This included the development of the local device software with various interfaces, as well as a cloud solution and a web application for our end users. I would particularly like to highlight the structured approach and close coordination throughout all phases of the project. We are very satisfied with the result and can recommend QuickBird without reservation."

Prof. Dr. med. H.P. Zenner
Managing Director Digitineers GmbH & Co KG

"QuickBird impressed us with their reliable implementation of medical device and digital health application requirements. The dedicated team combines technical expertise with in-depth knowledge of regulatory issues. The result of our collaboration is an app that has demonstrated significant effects in a randomized controlled trial and stands out for its high data security standards."

Jana Schwarz
COO of Off & Born Health

"QuickBird Medical handled the technical implementation of our Off & Born Aufrecht app and successfully brought the product to market as an MDR medical device. In doing so, QuickBird Medical even acts as the medical device distributor and thus bears full regulatory responsibility during live operation. This allowed us to focus entirely on our core internal competencies. It was incredibly valuable that the team didn’t just work through requirements but strategically guided the product from the very beginning. Together, we designed the app to seamlessly combine guideline-based therapy with a positive user experience. This collaboration showed us what sets a specialized partner in the medical device sector apart. We couldn’t imagine a better partner for this product."