Product/Service

Medical Devices

Source: QuintilesIMS
In a world of challenging and dynamic regulation, effective management of regulatory issues is essential to the maintenance of your business and to new product introduction.

In a world of challenging and dynamic regulation, effective management of regulatory issues is essential to the maintenance of your business and to new product introduction. This environment creates the need for robust systems and detailed knowledge of medical device requirements.

Quintiles helps medical device companies bring products to market — and keep them there — by efficiently and cost-effectively providing the right regulatory, clinical development and post-approval programs. We help you to:

  • Plan and execute clinical trials
  • Prepare documentation, such as:
    • 510(k)
    • IDE
    • PMA
    • PDP
    • CE Mark submissions
  • Design quality systems
  • Develop reimbursement strategies
  • Meet post-marketing surveillance requirements

The goal is to provide you with a full spectrum of services that help you meet the requirements of the Medical Device Directives (AIMDD and MDD), the In Vitro Diagnostics Directive and related directives.