Medical Device


ICON’s dedicated medical device team understands the unique requirements of medical devices and diagnostics, providing strategic support and tactical solutions for traditional, in vitro diagnostic, and software devices.
 
  • Medical Device Strategy and Market Access – expertise to guide new product development, and product/portfolio enhancements, including support for pharma clients seeking to expand into medtech with combination products and companion diagnostics.
  • Product Lifecycle Expertise – consultancy services and support throughout the product life cycle including: commercialisation and reimbursement planning; strategic regulatory consulting; quality systems development and implementation; clinical evaluation development and study construct; regulatory submissions and dossiers; post market surveillance, post market activities to support future product enhancements and entry to new markets.
  • Comprehensive Clinical Operations – global services in the US, Europe, Asia and South America, to address all aspects of medical device product clinical development, supporting all studies from first in man to large scale post marketing programmes. Services offered include: study management, from in-house teams or resourcing; imaging, data management, E-solutions; lab services, safety and CEC management; medical writing; auditing and QMS.

Insights on recent FDA guidance on Medical Device Adaptive Trials

Vicki Anastasi, VP and Global Head Medical Device and Diagnostics Research, recently spoke with Medical Design & Outsourcing about the challenges and opportunities of using adaptive trial designs in medical device development.