Medical Device and Diagnostic Expertise

We can help you build strong development strategies, whether a medical device is targeted to domestic or global markets. We understand the unique challenges of medical device development: intense competition, precise regulatory requirements and management of the product over its life cycle.

GCR has the global resources and local regulatory knowledge to facilitate effective strategies for approval. Our highly experienced medical device specialists provide innovative, results-focused support for our clients’ clinical and regulatory needs.

medical devices

Comprehensive Development Services

GCR’s cross-functional medical device and diagnostic product development team is comprised of clinicians, clinical operations experts, regulatory experts and biostatisticians. Our experts have deep experience in development planning and regulatory representation across a wide range of technologies and platforms, including companion diagnostics. GCR offers full-service consultation for medical device and diagnostic development across multiple therapeutic areas, including:

  • High-quality strategic consultation for device and combination product development
  • Customised regulatory submission preparation
    • Pre-submissions for early consultation and interaction with regulatory authorities
    • Clinical trial authorisation (CTA) and investigational device exemptions (IDE)
    • Marketing authorisation – 510(k) premarket notification, premarket approval (PMA) application and marketing authorisation application (MAA)
    • Humanitarian device exemption (HDE)
    • Requests for designations (RFD) 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/post-clearance support to maintain the safety, effectiveness and performance of the device throughout its life cycle
    • Registration and listings, labelling updates, design changes and enhancements, corrections, MDR reporting and recalls,
    • Post-approval studies
  • Submission updates to regulatory authorities
    • Annual reports and changes requiring pre-approval or notifications