Quality and Regulatory

Our commitment to quality ensures that our products and services meet or exceed the highest standards set by the United States Food and Drug Administration (FDA), the European Community, and other internationally recognized agencies. We maintain an industry-wide reputation as an award-winning manufacturer with high quality standards through enforcement of stringent clinical and regulatory requirements.

Our Quality Policy

At Integer I own Quality. Improving patients’ lives around the globe, one device at a time.

We achieve this by:

• Understanding our customers and proactively responding to their needs;
• Operating a compliant, effective, and efficient quality system delivering differentiated performance;
• Fostering a collaborative, accountable culture where quality is built into everyone’s daily work;
• Delivering relentless continuous improvement to enhance outcomes for patients, customers, and Integer.

Physician Advisory Board

As part of our commitment to medical device innovation, we maintain physician advisory boards across our coronary and vascular market segments. Our network of clinical experts and thought leaders include interventionalists (radiologists, cardiologists and neuroradiologists), surgeons (vascular and neurovascular), electrophysiologists and allied health professionals. To address unmet clinical needs and new technology development opportunities, we often collaborate with physicians in the following areas:

• Evaluation of new product and technology concepts, including product features, components, and/or compatibility with interfacing devices.
• Input on targeted improvements of existing products, including product features, components, and/or compatibility with interfacing devices.
• Participation on advisory or focus panels regarding market-specific product research and development.
• Consulting services to develop product requirement specifications and indications for use.

Medical Device Registration

Our quality management systems meet or exceed the highest standards set by the FDA, the European Community and other internationally recognized agencies. Our 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 as noted below.

Product Analysis

Our experienced scientists and engineers evaluate a range of material- and performance-related problems associated with the manufacture and operation of medical devices and components.