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?

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:

  • Medical devices & healthcare
  • Medical Device Regulation
  • Market access & reimbursement
  • Digital health
  • Strategy, marketing & sales
  • Clinical trails


We’d love to learn more about your project!
Contact us!