- 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?
WHAT IT’S ABOUT
Evidence-based digital therapeutics will become an inevitable driver of digital health.
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Digital Therapeutics
Digital Medicine
Digital Health
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.
Regulations
#regulations
#regulationsmobile
Cloud
#cloud
#cloudmobile
Law
#law
#lawmobile
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Certification
#certification
#certificationmobile
Patient
#patient
#patientmobile
AI
#ai
#aimobile
Doctor
#doctor
#doctormobile
Wearables
#wearables
#wearablesmobile
Devices
#icon
#iconmobile
scope of services
Our competencies support all stages of the value creation process: from product ideation to lifecycle management.
Services in
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?
Services in
Clinical Evidence
- 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)?
Execution excellence throughout the process
Project Management
- Do you need support in project setup and planning?
- Do you require project management and controlling?
- Do you require standard operating procedures?
Communication & Change
- Are you ready for your stakeholder management?
- Do you have a change management plan?
- Are you fit for internal/external communication?
Financing
- Do you have a financing strategy?
- Do you need to pitch to investors?
- Are you ready to contact and negotiate?
- Do you need support for grant application?
Legal advice and IP
- Need a legal check, legal advice, or a contract?
- Do you need advice for regulatory/compliance/reimbursement?
- Are you ready for data protection/IT security?
- Do you need support in a judicial/official dispute?
- Do you have a thought-through IP strategy?
- Any support for brand/patent assessment/filing?
- Are you ready for license negotiations?
Staff / Coaching / Recruiting
- Do you need advice for your target organization?
- Do you require headhunting to find key staff?
- Management or leadership coaching required?