Medical Device

ICON understands the unique requirements of medical devices, diagnostics, and combination drug/device and biologic/device products.

ISO 9001-2008 Certification

ICON provides dedicated medical device and consulting services, focused on delivering strategic regulatory planning and support, US FDA and international regulatory submissions, global clinical trial design and execution, and quality assurance and compliance services to address the US FDA Quality System Regulation (FDA QSR) and ISO 13485.

ICON’s medical device services are certified as conforming to the Quality Management System Requirements ISO 9001:2008. These services include:

  • Regulatory document development, preparation and submission, including Investigational Device Exemptions (IDEs), Premarket Notifications (510(k)s), Premarket Approval Applications (PMAs) and Technical Files
  • Clinical trial design, study management, monitoring, data management and statistical analysis
  • Quality system design, implementation, training, auditing, and compliance assistance to ensure compliance to US FDA Quality System Regulation, ISO and CEN standards, and Canadian and European Union (EU) quality requirements
  • General consulting and special projects