Clinical development plan

REQUIRED CLINICAL DEVELOPMENT PLAN

For the clinical evaluation of medical devices, it is new, according to the EU MDR, that manufacturers may have a clinical development plan. including a plan for clinical follow-up.

As a result, the specification, in addition to the normative and technical requirements for the new product, also includes clinical planning for evidence of clinical safety, minimal stress and effective benefits.

Our solution

Clinical Support & Writing.

The Clinical Assessment Body, Prof. Zenner and Partners, can provide the company with the preparation of the clinical development plan.

Our proprietary procedures:

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.

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