ISO 14155
Health & Medical Device
Clinical investigation of medical devices for human subjects - Good clinical practice
ISO 14155 is 'Clinical investigation of medical devices for human subjects -Good Clinical Practice (GCP)', which provides guidelines for clinical investigation principles, procedures to be carried out, and information to be collected. By conducting clinical investigation according to ISO 14155, it is possible to collect objective and reliable scientific clinical data while protecting the safety and health of subjects. In addition, not only the EU, but also United States, Canada, Brazil, Australia, Japan, China, and Russia have recognized medical device clinical investigation and clinical data based on ISO 14155, so their importance and efficiency will increase further.
ISO 14155:2011 Requirements
ISO 14155:2011 is a standard that introduces not only the GCP, but also the concept of research review by sponsors, researchers, and sites related to the clinical quality management process. It enables accurate and reliable clinical data collection with ethical considerations and a step-by-step approach to clinical investigation.
The importance of ISO 14155
Proper design of the clinical investigation plan is essential. Failure to disclose the proper rules and procedures for data collection is very important as it can result in the medical device manufacturer's safety and performance claims being insufficiently supported. In addition, compliance with this standard is vital evidence that the rights, stability, and well-being of subjects are guaranteed and that clinical investigation data are reliable.
This standard helps following
Estimated Effectiveness of ISO 14155
Quality Management System Certification and Audit Specialist
In general, approval of medical devices requires implementation of a quality management system. IGC performs quality management system certification, audit and factory audit in accordance with most international regulations and standards, allowing customers to reduce time and cost and receive integrated inspection and audit.
Provision of the best solution
IGC provides testing services necessary to enter the major medical device market in accordance with international standards and regulations.
Partnership with professional groups
IGC has accumulated expertise in technology and regulation for medical devices for a long time, and is consistently trusted by various organizations ranging from global manufacturers to local research institutes.
IGC’s Competency
From May 2020, when MDR is fully applied, clinical data and research results based on ISO 14155 will be required for the export of medical devices to the EU. IGC's medical device clinical experts will conduct a GCP compliance review for your clinical investigation and provide corrective action recommendations. IGC has the best Competency to
· Clinical investigation management and monitoring of Medical device
· Design of medical device clinical investigation research and Support of protocol development
· Review of clinical investigation report
· Review of Clinical Trial Master File
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