Reimbursement of Medical Apps (DiGA)
Do you need help with clinical investigations, CE certification, Fast-Track Procedure or distribution of your Digital Health Application (DiGA)?
Let us support you with our expertise and experience.
Since 2020, right from the very beginning of the Fast-Track Procedure, we at AMS have been supporting and advising clients from app manufactures and start-ups to pharmaceutical companies in various steps of the lifecycle management of DiGA.
Dr. Gabriele Feldmann
Clinical Operations Manager
With a robust scientific foundation in pathophysiology and pathobiochemistry, Gabriele has been a dedicated professional in clinical research for over 30 years. Her extensive expertise spans site selection, monitoring, and project management across international studies covering all phases of development. Gabriele specializes in medical device investigations, overseeing studies involving devices across all risk classes.
Gabriele has established and nurtured a team of AMS experts, focusing on this area of clinical research. She provides tailored consultancy to small and medium-sized sponsors, guiding them through the planning and execution of pivotal studies and Post-Market Clinical Follow-up (PMCF) investigations. Her strategic insights and hands-on experience ensure the success of complex medical device studies.
Gabriele’s commitment to advancing clinical research through innovative solutions and collaboration makes her an invaluable asset to AMS and its mission to improve healthcare outcomes.
Your service expert
Dr. Gabriele Feldmann
Clinical Operations Manager
Our services include
25 years of experience
Your clinical investigation or epidemiological study is in very good hands with us, based on more than 25 years of experience in more than 800 clinical studies in numerous indications.
DiGA Fast-Track Procedure
We prepare the application for the DiGA Fast-Track Procedure and the evaluation concept for you, including a systematic data evaluation from previous studies on your app and a clinical investigation plan with all required statistical considerations.
CE certification
Together with partner companies from our network we support you with the CE certification of your health app.
Consultation of the Innovation Office
Do you need support during the consultation of the Innovation Office of the Federal Institute for Drugs and Medical Devices (BfArM) as part of the Fast-Track Procedure? We are at your side – during preparation and/ or the consultation itself.
Clinical Investigation Report
Our medical writing department will summarize the results of your DiGA study in a clinical investigation report and take over the preparation of publications for you.
Sales strategy
If you need support in distributing your DiGA, AMS can develop a suitable sales strategy, train your sales representatives or provide external sales staff.
Puplications
- Despite some remaining hurdles, DIGA is a successful model for market access, which is also being applied in other countries, explain Kirsten Dahm from AMS and co-authors in PMQM224-p18-27-Dahm-et-al
References
