6.0 Clinical Writing
REQUIRED CLINICAL DEVELOPMENT PLAN
The Clinical Assessment Body, Prof. Zenner and Partners, can provide the company with the preparation of the clinical development plan
MEDICAL WRITING IN PATENTING THE IDEA FOR A MEDICAL DEVICE
For strategic decision-making and patenting before entering into cost-intensive development, Prof. Zenner and his partners can evaluate product ideas from a clinical perspective in order to clinically secure the entrepreneurial or contra decision. In addition to extensive experience in clinical evaluation, in-house development and use (eg active neuroimplants), there are also proprietary patents [1,161 KB] for medical devices.
FORMULATION OF THE CLINICAL INTERPRETATION OF PRECLINICAL TESTS
The clinical evaluation center Prof. Zenner and partners can support the company in the clinical interpretation of the preclinical tests and their evaluation and documentation.
CLINICAL WRITING TO PREPARE MARKET APPROVAL
The clinical evaluator Prof. Zenner and Partners can assist the company in the conformity assessment procedure with process-compliant documents and clinical writing.
The untried Scrutiny method can be completed more easily with convincing clinical writing.
The clinical evaluator Prof. Zenner and partners can support the company in the Scrutiny process through clinical formulations.
The clinical evaluation has a special impact on risk management.
The clinical evaluator Prof. Zenner and partners can assist the company with the clinical writing of the risk management file.
The existence of clinical data for clinical evaluation is not always mandatory.
If applicable on a case-by-case basis, the Clinical Assessment Body, Prof. Zenner and Partner, may assist the Company in providing a rationale for waiving clinical data in a clinical evaluation.
Continuous post-marketing clinical monitoring.
The Clinical Assessment Center, Prof. Zenner and Partners, can assist with post-market clinical follow-up as part of the PMS clinical process and Post Market Surveillance Plan / Report (PMS), Post Market Clinical Follow-up Report (PMCF), Periodic Safety Update Report (PSUR), Summary of Safety and Clinical Performance (SSCP) and Clinical Evaluation / Performance Summary Reports.
CLINICAL ASSESSMENT OF THE REFUNDABILITY OF MEDICAL DEVICES BY GKV.
The Clinical Assessment Body Prof. Zenner and Partners can provide clinical evaluation and documentation for G-BA / NUB procedures.