Fast-Track Process for digital health applications

Let the AMS DiGA expert group help you generate solutions:

For the first time in Germany digital health applications (Digitale Gesundheitsanwendungen, DiGA) can be reimbursed by statutory health insurance according to the Digital Healthcare Act (Digitale-Versorgung-Gesetz, DVG). Manufactures have to engage an independent institute to fulfil the legal requirements. AMS as a manufacturer-independent contract research organisation (CRO) accompanies you on the way from a CE class I or IIa digital medical app or web application to its provisional or final listing in the DiGA directory of the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM).

 

Read more or find out how AMS DiGA experts will meet your needs:

 

 

• 2021 – New Literature Search tool launched • 2021 – DIGA dossier submission pioneer • 2021 – NIS-eTMF launched • 2021 – MDR readiness, AMS prepared for Medical Device Trials under new regulation • 2021 – VO (EU) 536/2014, AMS among the first 100 participants in the EMA CTIS Trainer Programme • 2021 – eSignature, AMS introduced DocuSign® • 2017 – Globally unique AMS-ePRO® features • 2016 – CRO of the year award •

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