The areas of Software as a Medical Device and digital health applications are changing quickly. This is driven by technological advancements, but regulatory pathways are also becoming increasingly difficult to understand and successfully manage. That’s where our expertise comes in.
Whether you’re developing an AI-driven diagnostic tool, a remote patient monitoring app, or a digital therapeutic, RQM+ provides the digital know-how to help you succeed. As the leading MedTech service provider with 40+ years of experience, RQM+ uses deep regulatory, clinical, and market access expertise to bring innovative digital health solutions to patients worldwide.
Your Partner in SaMD and DiGA Success
We provide end-to-end support for SaMD and DiGA developers:
-
Regulatory Strategy & Compliance
Expert guidance on FDA SaMD pathways, EU MDR, ISO 13485, IEC 62304, and the German DiGA fast-track approval process.
-
Clinical Evidence Development
Study design, patient engagement strategies, and ISO 14155-compliant clinical investigations.
-
Market Access & Reimbursement
Support for DiGA registry applications and payer requirements in the U.S., Europe, and beyond.
-
AI and Software Validation
Compliance with evolving AI/ML and cybersecurity regulations for digital medical devices.
Accelerate Market Access With the German DiGA Model
Germany’s DiGA fast-track pathway offers a streamlined process for software-based medical products to become prescription digital health applications that are reimbursed by statutory health insurers.
RQM+ supports DiGA submissions with:
- Regulatory strategy and eligibility assessments
- Study design and execution aligned with BfArM requirements
- Clinical and real-world evidence generation for reimbursement
- Ongoing compliance, post-market surveillance, and payer negotiations
For U.S. and global digital health companies, DiGA represents a unique opportunity to secure early reimbursement and establish a foothold in the European market.