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Your Health App Into The DiGA Directory

HPZenner Clinical CRO Germany | Phone: +49-7071 49-645 | Mail: office@hpzenner.com

DiGA

Your Health App´s jumpstart into the world´s largest Health App reimboursement market
Since October 2020, the world's largest per capita spending health care system with 72 million socially insured patients has been opened for health apps. The internationally unique feature: BfArM-listed apps can be prescribed to patients by their doctor free of charge. The manufacturer receives payment directly from the health insurer. Those health apps carry the "DiGA" designation. HPZenner Clinical provides you with the full scientific evidence to go for the BfArM´s "Fast Track" to enter this unique market by getting BfArM´s "DiGA" designation for your health app.

DiGA

Your DiGA success is our mission
As a manufacturer-independent institute within the meaning of § 139e Paragraph 4 SGB V, HPZenner Clinical has the experience and knowledge for your DiGA success: With its DiGA Clinical Study Program (DCSP) HPZenner Clinical already made a significant contribution to the successful inclusion of one of the first DiGAs in the BfArM DiGA directory in October 2020. An evaluation concept and study protocol for the BfArM have already been drawn up for other manufacturers. Do not hesitate to call +49 7071 49645 or to mail to office@hpzenner.com.

CRO HPZenner® Clinical
is proud to have contributed significantly to the successful inclusion of one of the very first DiGAs in the BfArM directory, ready in 2020. HPZenner CRO is a Germany based European CRO for the medical device and pharmaceutical industry. For manufacturers we offer support for clinical evaluations and clinical studies in Europe and Germany according to MEDDEV 2.7/1 rev 4, MDR and DiGAV as well as AMG.

Analytical. Clinical. Innovative.

Two Brands - One Company

HPZenner® Clinical: The CRO

HPZenner® CRO is the CRO (Clinical Research Organization) for manufacturers of medical devices. We offer full service or part service for clinical evaluation and clinical studies according to MEDDEV 2.7 / 1 rev 4, MDR and DiGAV.

The CRO HPZenner Clinical is the brainchild of Hans P. Zenner, M.D., Distinguished Professor of Head&Neck Surgery at The University of Tübingen, Germany. His CRO experience goes back 25 years when he designed and directed the clinical study and evaluation of self co-developed electronic class III implants acc. to MPG and FDA regulations. Today, our mission includes the (re) certification and approval of medical devices according to MDR or DiGAV. We are expert Medical Doctors who have been certified by the medical association.

Our processes are highly digitized. We work with the Digitineers® Digital Backbone 1.0 with digital mapping of essential steps in the organization of clinical evaluation processes.

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Digitineers®: The Digital Medicine Powerhouse

is the digital medicine powerhouse from HPZenner Clinical. At Digitineers we work with customers and partners to shape the new global digital medicine. Whilst we contribute to a major economic shift that's already underway it is our philosophy to design machines that preserve humanity.

Digitineers is the brainchild of Medical Doctor, entrepreneur and investor, Hans P. Zenner. His experience goes back 25 years when his team accompanied the successful development of electronic class III implants up to CE certification. Today HPZenner is breaking new ground with Digitineers up to hybrid AI in medicine. We develop digital and digitized products for customers along clinical value chains in medicine, medtech and pharmaceuticals. Digitineers combines product architecture and design with medical knowledge and experience in the context of digital knowledge and thinking. And: we have built networks for a valuable transfer of knowledge. The result: an eco-system with digital thought leaders, partners and customers with diverse inspirations for everyone involved.

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Welcome by the CEO

Hans P. Zenner, M.D., MBA
Hans P. Zenner, M.D., MBA Founder & CEO

"We are proud of our internationally renowned partners in all clinical disciplines who are the basis of our ability to pave the way for your success in Europe. Success Made in Germany." H. Peter Zenner, CEO, M.D., MBA

HPZenner® Clinical
GmbH&CoKG
Street: Bismarckstr. 66
Zip: D-72072
City: Tübingen, Germany
Mail: office@hpzenner.com
Phone: +49 7071 49-645


HPZenner® and Digitineers® are registered trademarks of H.P.Zenner Clinical GmbH&CoKG.
We are certified according to ISO 9001.