To achieve this goal we have selected QPack Medical™ system that accepted the validation documents and for each document the system created set of KPI (Key Performance Indicators) as well as KRI (Key Regulatory Indicators) that triggered QPack Medical alert system with Pre-Audit notifications. The overall idea was to define the development path in which the specific product shall be using and to match the perfect system that will control and governance each step in the development lifecycle. In this project the focus was on getting the project started on the correct regulatory path and have taken the initiative documents created by the R&D group into a preset system that control and governance the regulatory path selected by the organization. Orcanos Implementing NPI (New Product Introduction) for one of the legacy Israeli Medical Device company Elcam Ltd. 25.8% – Change in corporate priorities or strategy.40.2% – Funding not available (Second Round).More than that if there was a development behind those studies it was impossible to recreate the documentations requires utilizing their business potential.Īccording to the same research the following answers given to the question: Why did the company delay the research or development project? Were as follows: The unspoken rule is that at least 50% of the studies published even in top tier academic journals – Science, Nature, Cell, PNAS, etc… – can’t be repeated.

#8 – Ability to demonstrate effectiveness.Based 2,323 California biomedical companies research, here are the main 10 threats those companies has reported on

Elcam software