ISO 9001 | ISO 13485
ISO 9001:2015 is the standard used by organizations to demonstrate their ability to consistently provide products and services that meet customer and regulatory requirements and to demonstrate continuous improvement. ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
WRAP Certificate 128331
Having a WRAP certification shows potential buyers that you are dedicated to ethical and responsible business standards. It demonstrates that you obey the laws of your country, treat your workers with dignity and respect, and are conscious of the impact your operation has on the environment. The WRAP certificate is a recognized symbol of a commitment to uphold social and ethical standards.
Workplace Conditions Assessment
WCA is an industry-agnostic and widely accepted risk-based solution in our Supply Chain Assurance suite of services. It provides an on the ground support and expertise to help companies manage Supply Chain Due Diligence specific to social and labor conditions, health & safety, environment, and business practices.
Work Safety Standardization
Work Safety Standardization reflects the policy of "safety and prevention first". This policy of China points out the standardization and legalization of enterprise safety production. Furthermore, it provides overall risk management, process Control, performance management and continuous improvement.
Owners or operators of places of business (also called establishments or facilities) that are involved in the production and distribution of medical devices intended for use in the United States are generally required to register annually with the FDA. To look up our registration, please go to the FDA registration site and look up Medtecs.