Clinical Development

Medical Device / IVD

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

Bring Your Medical Device Product to Market with Speed and Efficiency

As China‘s foremost CRO service provider for Medical Device (MD) and IVD regulatory and clinical trials, we have established long-term cooperative relationships with over 2,100 manufacturers across 30+ countries in the past two decades. Our top priority is to assist your MD/IVD development and manufacturing process to cope with the ever-changing regulatory requirements globally.

  • Collaborated with Top 20 global medical device manufacturers
  • Enabled the first approval of AI based mobile APP medical device in China 
  • Over 4,500m2 testing lab space with CNAS/CMA certificated
  • Experienced in 380+ IVD regulatory and clinical trials
Clinical Trials in Medical Device/IVD
Regulatory Projects
Countries of Business Coverage

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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