Many states have adopted new approaches to licensing facilities. MEDVACON provides guidance and prepares certain state applications in accordance with practices the US FDA is acustom to seeing. Upon approval of the application by the state, MEDVACON provides guidance and professional consulting services regarding the implementation of the policies and procedures proposed in the application.
A State regulated medical facility is required to have an operating manual, essentially a Quality System. Such an operating manual requires policies and procedures, which must be developed, approved and managed and Management and staff employees must be trained. Based on certain state regulations stated procedure requirements and interpretation of the regulations, policies and procedures documents are required in the following areas with each area requiring subsections which MEDVACON will share as part of the consulting engagement:
MEDVACON's extensive experience in implementing Quality Management Systems for the pharmaceutical, medical device and biotechnology industries will enable the smooth implementation of your Quality System.