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 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.

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+

Integrated Solutions and Capabilities

Regulatory Affairs
R&D Testing
GMP Support
IVD Reagent
Audit Service
Clinical Trial Service
Monitoring & Safety
Statistical Analysis
Clinical Evaluation

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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