ISO 13485:2016 is an International Organization for Standardization (ISO) standard which represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices.
AS 9100D – The Aviation, Space and Defense industries have developed their own series of standards that are based on the internationally successful ISO 9001 standard. It defines the quality management systems standard for the industry. All major aerospace manufacturers (OEMs) and suppliers worldwide endorse and require certification to AS9100 as a condition of doing business with them.
21 CFR Part 820 (GMP) compliant
The requirements of 21 CFR Part 820 govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. GMP are the practices required in order to conform to guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products.
CFR 21 Part 11 compliant (MasterControl)
MasterControl is a document management software, also used by the FDA, specifically designed to help life sciences organizations ensure compliance with FDA regulations.