ISO 13485: 2012
ISO 13485: 2012 is an international standard that represents the needs for a comprehensive quality management system for the design and manufacture of medical devices. Though it is tailored to the industry's quality system expectations and regulatory necessities, an organization does not require being actively manufacturing medical devices or their components to look for certification to this standard.
CMMI
CMMI is a process improvement approach that provides organizations with the essential elements of effective processes that ultimately improve their performance. CMMI model is a process improvement maturity model for the development of products and services. It consists of best practices that address development and maintenance activities that cover the product lifecycle from conception through delivery and maintenance.
CE Marking
CE Marking is an European conformity mark. CE Marking on a product indicates that the product complies with legal requirement of European market. and the same can be sold with in European Union. CE Marking ensures that a product meets a minimum safety standard and product does not compromise with public safety. CE Marking is also applicable for manufacturers located outside European Union if they want to place their product in European union.
GMP
In different EU directives. A GMP is a system for making sure that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.GMP is an abbreviation for Good Manufacturing Practices. GMP is an initiative of the WHO. The main aim of GMP is to see to it that the products are good sufficient for utilization after the final outcome
