Clinical Development

Medical Device / IVD

Bring your medical device product to market with speed and efficiency.

A Global Partner for Medical Device/IVD Clinical Studies

As the largest Medical Device/ IVD regulatory and clinical trial CRO service provider in China, Tigermed has over 300 full-time experienced medical device clinical experts and researchers. With long-term cooperative relationships with over 2,100 manufacturers from more than 30 countries, and we are committed to streamlining your path to success and guiding your product to market.

As your global partner, we have a dedicated medical device and diagnostic team to design and conduct clinical trials and ensure that clinical studies can generate evidence to support future approval.

Clinical Trials in Medical Device/IVD
830+
Regulatory Projects
6,200+
Countries of Business Coverage
30+
Global Clients
2,100+

Our Scope of Service

Product market research

  • Research of product distribution
  • Research of clinical use of product

Product marketing strategy

  • Marketing strategy analysis
  • Estimation of pre-marketing costs and time

Product finalization

  • Design/finalization supports
  • Plant preparation/guidance in quality system establishment

Product verification
(design input testing)

  • Performance verification/investigational verification/rectification supports
  • Animal experiment/biological testing

Registration strategy planning

  • Registration strategy and steps
  • Registration path risk assessment

Marketing application

  • Clinical evaluation/clinical trial
  • Testing/dossier preparation/guidance
  • Registration application

Post-marketing supports

  • Post-marketing follow-up study
  • Adverse event/recall, collection and handling/regulatory support/training
  • Unannounced inspection supports/system inspection/overseas inspection supports/overseas promotion
  • Agent screening/GSP inspection

Product upgrade

  • Strategy development/feasibility assessment
  • Versatility
  • Variety
  • Value-based price

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