Methods

Intelligent clinical tools

Our seven implementation modules as intelligent tools for tailor-made solutions

Our proprietary implementation modules cover all of the typical issues faced by manufacturers - from initial advice on gap analysis, scientific advice, clinical assessment including clinical testing, clinical monitoring and clinical writing with regulatory compliant documentation to HR development, as well as process and quality optimization.

1.0 Medical Counselling & Scientific Advice

1.0 Medical Counselling & Scientific Advice

We can accompany you from the product idea to the approval to clinical PMS. The entire development period of a medical device can be described in many development phases by Prof. Zenner and...

2.0 Clinical Evaluation.

2.0 Clinical Evaluation.

According to the new EU MDR, proof of clinical effectiveness of a medical device and patient protection is usually provided by a specialist clinical evaluation...

3.0 Clinical Trial.

3.0 Clinical Trial.

If sufficient clinical evidence is not available to demonstrate the required clinical safety and performance of a product, clinical trials must be performed. Novel products, implantable medical devices, and Class III products must be on the .

4.0 Gap Analysis

4.0 Gap Analysis

The Clinical Gap Analysis of the Clinical Assessment Center Prof. Zenner covers existing gaps in clinical documentation ...

5.0 Clinical Support.

5.0 Clinical Support.

The entire development period of a medical device can be clinically supported by Prof. Zenner and his partners in many development phases. In addition, medical support for the clinical PMS ...

6.0 Clinical Writing

6.0 Clinical Writing

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.

7.0 Medical Strategy & Business Consulting

7.0 Medical Strategy & Business Consulting

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

Phone: (+49) 700-02 98 80 13
Email.: office@hpzenner.de

Munich Office

Oettingenstr. 8a
80538 Munich

Phone: (+49) 89 255-46434
E-mail: office@hpzenner.de