Customer Certification

NUGA WORLD WIDE CERTIFICATION

NUGA BEST has certified with FDA Registration as Class I Product which INDICATES the global standardization of quality system and conformed to the rules stipulated by the EU in terms of product safety, Health environment & Consumer protection.

NUGA BEST has got the Certification of EC ISO13485:2003 from ITC which INDICATES the global standardization of quality system set by the International Organization of Standardization to guarantee the quality of the product for its Design & Development, Manufacturing and service for combination Stimulator.

NUGA BEST also got certification from TUV Cert for Quality systems certification as per DIN EN ISO 13485, the standard DIN EN ISO 13485 provides the comprehensive REQUIREMENTS for quality systems established by medical devices manufactures. Unlike the former standard DIN EN 46001/2, it is internationally accept as an ISO standard. TUV CERT certification bodies posses the REQUIRED accreditations for the certification of quality management systems in the medical devices sector.

NUGA BEST got the Certification from Good Manufacturing Practice (GMP), is a system for ensuring that products are consistently produced and controlled according to quality standards. GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. There must be systems to provide documented proof that correct procedures are consistently followed at each step in the manufacturing process – every time a product is made.

The Commendation of CE means that a manufactured product has conformed to the rules stipulated by the EU in terms of product safety, health environment and consumer protection related regulations provided under the EU Directives. Any consumer product which may endanger the safety of the consumer must be accredited by EU and carry CE mark prior to MARKET distribution.