Clinical Trial For Medical Devices

Services scope:

●     Clinical trial——for medical device and diagnostic regent

Designation for protocol

Monitoring the clinical trial

Statistic and analysis for clinical trial data

Pre-clinical research

Clinical trial for imported medical device registration

Data management and statistical analysis

●     Registration consultation service——registration

 submission and imported registration submission

Consultation of registration in China

Consultation of medical device system

Out-source service

Consultation of medical device management

Translation for medical device dossiers

●     Training

Regulatory requirements training

Standard training

Management training

●     Data and information

Industrial database

Industrial analysis report

Industrial deployment report

Other custom reports

●     Patent

Professional communication platform

Patent assessment

Patent industrialization

Why choose us:

●     With a dedicated medical device team, including project managers, data managers, clinical monitors, biostatisticians, and regulatory and QA experts, Boji is uniquely able to support you through all phases of clinical trial development and testing. 

●     We will help you to design, implement, and manage a clinical trial for your device, diagnostic, or combination device that meets your business needs, whether to support a pre-market regulatory submission, drive product adoption, support product reimbursement, or monitor post-market product use.

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