Strategy, structure and processes
STRATEGIC AND ORGANIZATIONAL CONSULTING FOR THE MANUFACTURER'S STRATEGIC AND OPERATIONAL ACTION NEEDS
Strategic and operational need for action
The new EU regulation results in strategic and operational needs for the manufacturer, for each product as well as for the structures and processes of the company. Product and market influence the strategy for early, mid-term or late implementation. The status of the Notified Body must also be taken into account (it must be renamed, whereby a temporary or complete failure of the previous NB must be taken into account). Furthermore, the expiry date of the previous authorization, the completeness of the clinical data and the internal and external resources play an essential role.
Medical Stategy & Business Administration Consulting
Although the clinical evaluation of Prof. Zenner is primarily oriented towards the predominant benefit for the patient and the well-being of the patient, the manufacturer's value added chain with quality, effort and revenue can also be taken into consideration. Specialists with a degree in Business Administration (MBA) or international professional experience with global consulting firms (eg BCG) provide support at the interface of medicine and business with the re-designing of structures and processes of the manufacturer to fulfill the clinical requirements of the new EU MDR ,
Recovering / raising profits through G-BA / NUB procedure.
But we can also contribute to the direct generation of revenue by preparing the arguments for G-BA / NUB procedures .
Clinical Evaluation & Writing
The Clinical Assessment Body Prof. Zenner and Partners can provide clinical evaluation and documentation for G-BA / NUB procedures.
Human resource development
In this context, clinically-oriented personal training may be required in relation to the circumstances of the new EU MDR in order to secure or increase revenue.
The tailor-made personnel development measures of the Academy Prof. Zenner, if required also as an in-house event, are at your disposal.