Quality Management

DiGA certification: Your path to a prescription app in 3 months

Are you developing a digital health application and would like to have it approved as a DiGA (digital health application)? Then now is your chance to get your app listed in the official DiGA directory in just three months – with our support in the fast-track procedure.

DiGA certification allows your app to be prescribed and reimbursed by statutory health insurance providers – an enormous market advantage for you as a medical device manufacturer!

DiGA certification in 3 steps

The path to certification of your prescription app is complex:

Certification as a medical device,
Fast-track application to the BfArM,
Proof of positive effects on healthcare.

We are familiar with every step and are at your side with sound advice and many years of experience working with various healthcare companies.

Whether on site or digitally, our QM team will guide you through the entire process: from preparing the technical documentation to successfully registering your app in the DiGA directory.

Conclusion

Take advantage of your opportunity to gain market access and reimbursement!

Arrange a consultation – we will put your DiGA on the road to success.

Dilek Imre (info@sinovo.de) will be happy to advise you.