DIGITAL PLUS HEALTH

WE accompany YOU into a new era in healthcare

Strategic Consulting

Business models for digital health products, medical apps, DiGA (digital health application) and medical devices
„Is my product a medical device?”
- Costs / Duration / Requirements / Setup / Documents
- Intended Purpose / Risk Classification / Medical Claims / Patient-Related Medical Benefits / Care Delivery Improvements
- Advertising (German Medicines Advertising Act), Marketing and Sales
How to become a DiGA?

CE marking according to MDR, with focus on the technical file for digital health products and medical apps of risk classes I, IIa, IIb
Setup of Post Market Surveillance (PMS)
Definition and setup of software development process including all regulatory requirements for software-based medical devices and apps (software as a medical device)
Understanding of correlations and dependencies between medical device and DiGA requirements
Development of quality management system (QMS) according to ISO 13485
Support in planning and designing clinical trials

For digital health products and medical devices including consideration of all potential access routes
Also, as digital health applications (DiGA) via DVG (German Digital Healthcare Act) and the DiGA directory
Initiation and support of pilot projects and cooperation with statutory (GKV) and private (PKV) health insurances
Initiation of contracts with health insurances

Managing Partner & Founder of HEPICC GmbH, DiGA Factory Co-Founder, Expert in:

Managing Partner & Founder of HEPICC GmbH, DiGA Factory Co-Founder, Expert in:

We’d love to learn more about your project!