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?
Medical device registration
Strategic advice on CE marking in accordance with MDR for digital health products and medical apps of risk classes I and IIa
Setup of Post Market Surveillance (PMS)
Definition and setup of software development processes 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
Market Access
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
Who we are
Alexandra Jelen
Managing Partner & Founder of HEPICC GmbH, Expert in:
Platforms, portals & apps
Digital health
Software as a medical device
Medical device market approval & certification
Digital business models & agile processes
Market Access and health insurances
Gregor Jelen
Managing Partner & Founder of HEPICC GmbH, Expert in:
