Introduction
What is DiGA?
"Digitale Gesundheitsanwendungen" (DiGA) are digital health applications approved by Germany's Federal Institute for Drugs and Medical Devices (BfArM) for use within the statutory health insurance system. These apps empower patients to take control of their health through evidence-based digital solutions prescribed by healthcare professionals. DiGA represent a significant advancement in modern healthcare, bridging the gap between technology and patient care.
Proven track record
With over 20 years of experience and 4,500+ projects completed, IASON Consulting excels in navigating the complexities of medical devices and digital health, particularly DiGA approvals and regulatory compliance.
Multidisciplinary team
Our team includes experts in regulatory affairs, clinical evaluation, software development, data protection, and more. This ensures every aspect of your DiGA project is handled with top-tier expertise and professionalism.
Deep regulatory knowledge
We possess deep knowledge of BfArM requirements and the DiGA Fast-Track process. Our consultants stay updated on regulatory changes to ensure your digital health application meets all approval and reimbursement criteria.
DiGA Consulting
Our DiGA Consulting Services
We provide comprehensive guidance on navigating the DiGA Fast-Track application process. Our services include:
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Developing a tailored regulatory strategy aligned with your device goals.
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Assisting in the preparation and submission of all necessary documentation to BfArM.
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Liaising with regulatory authorities on your behalf to address queries and expedite approval.
DiGA consulting
Clinical Evaluation and Evidence Generation
Our team supports you in designing clinical studies to demonstrate the efficacy and safety of your digital health application:
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Crafting robust study protocols and methodologies.
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Ensuring compliance with clinical evaluation guidelines and standards.
Post-Market Surveillance
Our support continues after your product enters the market:
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Developing strategies for ongoing compliance and monitoring.
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Managing updates, reporting obligations, and renewals with regulatory bodies.
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IASON Consulting offers an AI-driven post-market surveillance solution that reduces PMS effort by up to 80%.
