What is Feasibility at CLAUSE? It is a a Productive Feasibility
Would you like to have qualitative, quick, productive, accurate reliable selection of the sites?
In Clause we have our own database of clinical sites and Investigators. This database is being formed on the results of our cooperation with the clinical sites and study staff, and is regularly updated.
Medical devices can only be introduced in the EU market after having been approved to be suitable, safe and effective.
Scope of Medical Device Clinical Studies:
US market is probably the most desired goal for a Medical Device manufacturer.
Precise knowledge of FDA world can transform approval process in a quick and convenient way.
We offer such services:
European Legislation regarding Medical Devices is in continuous development.
Understanding of the correct and current process of development and product life-cycle is essential to produce the correct documentation and obtain CE mark in a "time-saving" manner.
Technical File, Essential Requirements, Risk Management, Post-market Surveillance are all concepts you should perfectly know before planning the development of a new product.
Clause will help in all these:
CLAUSE ltd offers the full range of auditing and consulting services in the field of clinical research.