Medical Device Regulatory Standards | Integer Holding Corporation

Quality & Regulatory Standards

Integer’s commitment to quality ensures that your product’s regulatory standards meet or exceed the highest standards set by the U.S. Food and Drug Administration (FDA), the European Community and other internationally recognized agencies. Integer maintains an industry-wide reputation as an award-winning manufacturer with high quality standards through enforcement of stringent clinical and regulatory requirements. This provides customers security in knowing that clinical and regulatory requirements are inherent in all aspects of our business practices.

FDA Registered Sites

To build compliance to various regulatory and customer requirements, Integer maintains ISO 13485 certification and a quality management system that meets or exceeds FDA Quality System Regulation (QSR) requirements, as well as the highest standards set by the European Community and other international regulatory agencies.

Quality Systems Certifications

You can find the certifications for our facilities under our locations.

Medical Device Registration

Integer’s quality management systems meets or exceeds the highest standards set by the FDA, the European Community and other internationally recognized agencies. Seasoned clinical and regulatory experts work with regulatory authorities and notified bodies to seek regulatory approval of medical devices according to essential requirements outlined in the 510(k) and CE Mark regulatory approval processes.

Product Failure Analysis

Integer’s experienced scientists and engineers evaluate a range of material- and performance-related problems associated with the manufacture and operation of cardiac, endovascular, and advanced surgical medical devices and components.