Medical Device and Diagnostics Regulatory Expertise

PPD’s extensive experience in all classes of medical devices and diagnostics and exacting regulation requirements for a strong development and commercialization strategy help clients save time and money with their studies.

Whether a medical device is targeted to domestic or global markets, we can help you overcome the challenges of an ever-evolving global regulatory environment. With offices in more than 45 countries, PPD has the global resources and local regulatory knowledge to facilitate effective strategies for approval.

Comprehensive, focused services

Working closely with PPD’s medical devices clinical team, we offer full service regulatory support for medical device and diagnostic development.

Preapproval device support

• High-quality strategic consultation for device and combination product development
• Customized regulatory submission preparation
  • Clinical trial authorization and investigational device exemptions, including clinical trial authorization (CTA), investigational device exemption (IDE) and pre-IDE
  • Marketing authorization – 510(k) notifications, premarket approval application (PMA) applications and marketing authorization application (MAA)
  • Humanitarian device exemption (HDE)
  • Requests for designations for combination products
• Evaluation of notified bodies (NB), preparation for NB audits, preparation of technical dossiers
• Interaction/meetings with regulatory agencies at every stage of development
• Import and export consultation for global device development
• Due diligence to assess regulatory compliance

Post-approval device support

• Post-approval/post-clearance support to maintain the safety, effectiveness and performance of the device throughout its life cycle
• Submission updates to regulatory authorities