Performance Areas

Clinical Evaluation

Clinical Evaluation

The new EU regulations have the requirements for the burden of proof of safety and efficacy by means of clinical evaluation and if necessary. ..

Clinical studies

Clinical studies

If sufficient clinical evidence is not available to demonstrate the required clinical safety and performance of a product, clinical trials must be carried out ...

Clinical writing and documentation

Clinical writing and documentation

The clinical evaluator Prof. Zenner and Partners can assist the company in the conformity assessment procedure by means of process-compliant documents and clinical writing.

Preclinical testing

Preclinical testing

The planning and execution of a substantial part of the preclinical tests of the future medical device will naturally depend on the late ...

PMS

PMS

Continuous post-marketing clinical monitoring. After the market launch of the medical device, according to the new MDR (Annex XI ...

Product idea consulting

Product idea consulting

The question of redeveloping a product based on an idea touches on equally profound strategic, operational and economic ...

Patent consulting

Patent consulting

Intellectual properties often have to be secured by means of patents and can be used at the interface of technology and medicine medical writing ...

Distribution

Distribution

In the outpatient area, a reservation of authorization applies to the distribution of medical devices at the expense of the statutory health insurance. You may only after a positive decision of the ...

Process optimization

Process optimization

Specialists with completed additional training in Business Administration (MBA) or international professional experience in global consulting Firms offer at the interface of medicine and business management ...

TÜBINGEN / STUTTGART OFFICE

Bismarckstr. 66
72072 Tübingen
0700-02 98 80 13 (Ortstarif)
office@hpzenner.de

MUICH OFFICE

Oettingenstr. 8a
80538 Munich
089 255-46434