Medical Device Regulation | FDA and EU Requirements | Integer

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, we all own Quality through our daily activities and decisions that prioritize the patient by …

  • Developing & improving products, processes & services with clinical and technical expertise;
  • Creating and maintaining effective systems to meet quality, regulatory, customer & business requirements
  • Following the systems we have created together;
  • Proactively managing risk to the patient of the business.

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.

Medical Device Registration

  • Regulatory submission:  510(k) and CE Mark
  • Regulatory services: Design History File (DHF), technical file, design dossier,
    product classification / identification, product labeling / IFU, risk assessment and vigilance & post-market surveillance

Regulatory Reporting

  • Complaint handling & reporting
  • Investigation of complaints of adverse events
  • Medical device reporting of MDR & MDV reportable events
  • Supplemental / follow-up reporting

Regulatory Vigilance

  • Post-market surveillance & trending
  • Vigilance to ensure coordinated & timely corrective action

Quality Management System

  • Our global facilities are ISO 13485:2016 certified and undergo a stringent audit process 
  • Good Manufacturing Practices (GMPs)
  • Design control: risk management, design & development planning, organizational & technical interfaces, design input & output, design review, design verification, design validation and design transfer
  • Download a copy of an ISO certificate from one of our sites

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.

Material Failure Investigation


  • Pre- & post-production product contamination investigation
  • Collaboration with raw material suppliers to improve input quality


  • Root cause investigation
  • Failure analysis
  • Surface chemistry & adhesion of product bonds
  • Microstructure / mechanical properties
  • Materials formulation & validation

Scientific Support Services

  • Chemical analysis
  • Materials testing
  • Coatings efficacy
  • Design assurance testing