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Kalorienzählung
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.

Our expertise in DiGA consulting

Our expertise stems from a comprehensive understanding of both regulatory frameworks and software systems, supported by our multidisciplinary team of software developers and regulatory specialists.

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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.

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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.

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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.

Our dedicated team is always available to support you at every stage of your project.

DiGA Consulting

Our DiGA Consulting Services

We provide comprehensive guidance on navigating the DiGA Fast-Track application process. Our services include:

  • Developing a tailored regulatory strategy aligned with your device goals.

  • Assisting in the preparation and submission of all necessary documentation to BfArM.

  • Liaising with regulatory authorities on your behalf to address queries and expedite approval.

Offener Betrag
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Besprechungstisch
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:

  • Crafting robust study protocols and methodologies.

  • Ensuring compliance with clinical evaluation guidelines and standards.

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Post-Market Surveillance

Our support continues after your product enters the market:

  • Developing strategies for ongoing compliance and monitoring.

  • Managing updates, reporting obligations, and renewals with regulatory bodies.

  • IASON Consulting offers an AI-driven post-market surveillance solution that reduces PMS effort by up to 80%.

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Get in Touch

Mühlenstr. 23C
52832 Niederzier, Germany

+49 (0)2428 8096-44

  • LinkedIn

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