What is DiGA?

DiGA refers to CE-marked medical devices that leverage digital technologies to improve patient care. These applications are classified as low-risk (Class I or IIa) medical devices and are eligible for fast-track approval under Germany's pioneering DiGA program. This process not only accelerates access to the market but also ensures reimbursement through Germany’s statutory health insurance system.

DiGAs are particularly valuable in supporting those with chronic diseases, bridging gaps in care, and promoting better self-management of patient health. They integrate seamlessly into healthcare workflows, improving adherence and outcomes while reducing the burden on healthcare providers.

Learn more about revolutionizing healthcare with digital health applications with our DiGA whitepaper.

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The RQM+ Advantage for DiGA and SaMD Development

At RQM+, we specialize in navigating the complex regulatory environment surrounding digital health. With decades of experience and an unmatched depth of knowledge, our team ensures your DiGA or SaMD meets all regulatory requirements. From ISO 14155-compliant clinical investigations to ensuring MDR compliance, we support every stage of development.

Our experts also ensure you generate the highest-quality clinical evidence, facilitating the successful listing of your DiGA in the BfArM registry or the approval of your SaMD by global regulatory bodies.

DALL·E 2024-06-19 12.26.14 - A doctor prescribing a digital health application to a patient in a modern clinic setting. The patient is holding a smartphone, and the background sho

Innovative Technology Solutions

RQM+ goes beyond traditional regulatory consulting by offering advanced digital tools that accelerate the development and approval of your digital health applications. Our FERN.ai platform uses AI and machine learning to streamline regulatory documentation, manage clinical data, and optimize regulatory submissions—significantly reducing time-to-market.

We’re at the forefront of digital health technology, helping you harness the power of AI to bring innovative, patient-centric solutions to life.

Discover how our technology accelerates success. Learn more about FERN.ai.

Comprehensive Post-Market Surveillance

Your digital health application’s journey doesn’t end at approval. RQM+ provides ongoing support through comprehensive post-market surveillance to ensure continued compliance and performance. We collect real-world data, conduct adaptive studies, and track patient outcomes to safeguard your product's long-term success.

Our robust post-market services ensure that your DiGA or SaMD maintains its regulatory status and continues to deliver value to patients and healthcare providers.

Ensure compliance beyond market approval. Explore our post-market services.
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Why Partner with RQM+?

RQM+ offers the full spectrum of services for digital health applications, from regulatory consulting to clinical trials, lab services, and reimbursement strategies. With over 40 years of experience in MedTech, we understand what it takes to bring complex digital products to market. Our global reach ensures that your digital health application is compliant in every region where you seek approval.

Your digital health solution deserves the best partner. Partner with RQM+ today.

Ready to Accelerate Your Digital Health Journey?

DiGA and SaMD are shaping the future of healthcare. Whether you're in the early stages of development or preparing for market approval, RQM+ is the partner you need to succeed. Book a consultation today.

 

We are passionate about your success. Tell us more about your needs so we can help.

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