2.0 Clinical Evaluation.
Clinical evaluation by means of literature and equivalence procedures
We are aware of the ethical imperative of avoiding, as far as possible, the burden of and risks to patients through clinical trials. The literature and equivalence procedure established at the clinical assessment center Prof. Zenner may, in appropriate cases, allow the final question of the acceptability of the benefit / risk ratio to be taken into account after taking into account the patient's well-being even without a complex clinical trial. As a result, it may additionally succeed to represent economic latitudes of the manufacturer taking into account the patient's welfare.
We have decades of extensive experience as LCP with clinical MPG tests up to class III / active implants. The fulfillment of clinical trial requirements for medical devices can be supported by Prof. Zenner and Partners through the creation of an Investigator's Brochure as well as by providing patient education and consent information. In addition, advice on the preparation of the test plan in accordance with DIN EN ISO 14155 and the clinical evaluation of the results can be provided. Also, the clinical evaluation center Prof. Zenner can support the DIMDI application for clinical trials and contribute to the completeness of the application documents.
On a case-by-case basis clinical data may be waived in a case-by-case assessment on clinical grounds. If applicable, the Clinical Assessment Body, Prof. Zenner and Partner, may assist the Company in providing a waiver of clinical data. .
THE RIGHT MEDICAL REASON FOR CLASSIFICATION OF THE MEDICAL DEVICE CAN REDUCE DEVELOPMENT EXPENSES.
With a medically justified clinical evaluation, Prof. Zenner and partners can facilitate the correctly justified classification and thereby represent the economic latitudes of the manufacturer, taking into account the patient's well-being.
A clinical evaluation almost always now also legally required for stand-alone software.
Clinical Equipoise, established at the Clinical Assessment Office, Prof. Zenner, allows us to answer the final question of the acceptability of the benefit / risk ratio of stand-alone software, taking into account the patient's well-being.
The untried Scrutiny procedure is easier to complete with clinical support.
Clinical Assessment Center Prof. Zenner and Partners can provide clinical support to the company in the Scrutiny procedure.
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.
NECESSARY MEDICAL ASSESSMENT FOR RECERTIFICATION
The Clinical Assessment Body Prof. Zenner and Partners can perform the clinical evaluation and documentation at the recertification.