- Is your business model and business plan validated?
- Do you have a detailed product plan?
- Do you have a regulatory strategy and intended use?
- Have you checked the DiGA/DiPA fit?
- Are you aware of all reimbursement options?
- Is your product portfolio future-proof?
Digital therapeutics, a subset of digital medicine, are evidence-based therapeutic interventions driven by high-quality software programs to prevent, manage, or treat a medical disorder or disease.
Digital health refers to the use of digital technologies to improve healthcare outcomes, while digital medicine specifically uses these technologies for medical diagnosis, treatment, and prevention.
Regulatory Affairs, Development
- Is your Technical File and QM-System ready and compliant?
- Do you need help within the CE-marking process?
- Does your IT security fit to DTx requirements?
- Does your product fulfill DiGA/DiPA requirements?
- Are you ready for a technical due diligence?
- Any mobile/cloud/IoT development gaps ahead?
- Are you set up for lifecycle management and data analytics?
- Do you need to outsource development?
- Do you need a sponsor for a clinical study?
- Would you like to optimize your clinical strategy?
- Do you need help with your study design and execution?
- Do you need statistical data analysis support?
- Are you ready for BfArM?
- Do you need support with a DiGA/DiPA application?
- Do you need clinical evaluation support (CEP/CER)?