ISO 14155

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.

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  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.

  • 1. Scope
  • 2. Normative reference
  • 3. Terms and definitions
  • 4. Summary of good clinical practice (GCP) principles
  • 5. Ethical considerations
  • 6. Clinical investigation planning
  • 7. Clinical investigation conduct
  • 8. Suspension, termination, and close-out of the clinical investigation
  • 9. Responsibilities of the sponsor
  • 10. Responsibilities of the principal investigator

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  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 :

  • 1. Identification of all possible risks associated with medical devices
  • 2. Clinical data related to safety and performance can be collected
  • 3. Protecting patient safety and welfare
  • 4. Device’s conformity assessment

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  Estimated Effectiveness of ISO 14155

  1. 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.

  2. Provision of the best solution

  IGC provides testing services necessary to enter the major medical device market in accordance with international standards and regulations.

  3. 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.

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  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 :

  • 1. Clinical investigation management and monitoring of Medical device
  • 2. Design of medical device clinical investigation research and Support of protocol development
  • 3. Review of clinical investigation report
  • 4. Review of Clinical Trial Master File