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Support of medical device development

Taking advantage of many years of accumulated rich experience and know-how as a CRO
We can respond flexibly and quickly to every consultation.

In cooperation with "SRD biological Center" which is a company of SRD group, we can be efficient and provide a total support with our extensive experience in clinical trials and regulatory applications, from the stage of product development, biological safety testing, clinical trials, etc. to attain the approval of medical equipment and materials.

Flow of development work

Flow of development work * Biological safety study of medical device and materials
(It will be carried by the SRD Biology Center Co., Ltd. which is part of SRD groupSRD)

Service contents:

  • Pre-development Regulatory Affairs consulting
  • Consulting for PMDA consultation
  • Confirmation of the required study
  • Feasibility investigation
  • Sites selection
  • Monitoring
  • Quality Control
  • Case registration / Medical device allocation
  • Medical device management / storage
  • Data management / Statistical analysis
  • Medical writing
  • Safety management / support
  • GCP Audit
  • Support of written survey
  • Consulting for Regulatory affairs application
  • Support for elaboration of various application documents
  • In-Country Caretaker

Control study

  • Clinical trial
  • Clinical research
  • Investigator Initiated Trial (IIT)
  • Post-marketing survey, etc.
  • With our simple team work system, we can conduct any work quickly and smoothly and thus, achieve it at low cost.
  • We improve the efficiency by thinking ahead of the work such as written surveys.
  • Our specialists for clinical study and Regulatory Affairs applications will steadily provide support from the stage of product development until the application for approval.