Medical Device / IVD

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 1,900 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 430+ IVD regulatory and clinical trials

Clinical Trials in Medical Device/IVD

940+

Regulatory Projects

5,900+

Countries of Business Coverage

30+

Customers

1,900+

Integrated Solutions and Capabilities

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

We Have the Expertise You Need to Successfully Execute Your Medical Device/IVD Studies

Uniquely focus on Medical Device/IVD
An innovative service platform with 20-year industry experiences
Full life cycle services
Product market research\product finalization\registration strategy planning\clinical trial\post-marketing supports
Industry leader
Innovative products/cutting-edge products. Participating in the revision of industrial standards/guidelines
Dedicated service team
Regulatory affairs specialists\clinicians\biostatisticians\life sciences & clinical background
Extensive project experience
A broad range of therapeutic area, more than 200 registration certificates each year

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