Planning Stage
At the planning stage of medical device development, it is essential to accurately determine whether clinical evidence is required and identify the appropriate regulatory pathway based on the product’s classification, class, intended use, and the availability of existing data.
Intoinworld systematically develops clinical and regulatory strategies for medical devices through a comprehensive review of product characteristics and Korean regulatory requirements.
Service Scope
- Review of medical device classification, class, and the need for clinical evidence
- Assessment of applicable criteria for clinical investigations and other human subject studies
- Definition of the scope of testing required in Korea and evaluation of the potential use of overseas data
Operation Stage
During the execution stage of a medical device clinical study, selecting appropriate study sites, preparing essential documentation, and ensuring safety management are critical.
Based on extensive experience in medical device clinical operations, Intoinworld supports stable study execution from site initiation through study conduct and monitoring.
Service Scope
- Selection of study sites and investigators suited to the product characteristics, including tertiary hospitals, specialty clinics, and dental clinics
- Support for drafting and submitting essential medical device clinical documents, including the clinical investigation plan and informed consent form
- Support for device-specific evaluation items, such as usability and performance assessments, as well as safety monitoring
Data Utilization Phase
Data generated through medical device clinical studies serve as key evidence not only for Korean regulatory approval, but also for global registrations and subsequent development strategies.
Intoinworld systematically supports the full process—from preparation of regulatory submission documents to global filing strategies and post-market evidence generation—by assessing the regulatory acceptability and strategic value of Korean clinical data.
Service Scope
- Support for preparation of MFDS submission documents and Clinical Evaluation Reports
- Review of strategies for leveraging Korean clinical data in global regulatory submissions
- Development of follow-up strategies for post-market surveillance (PMS) and generation of additional clinical evidence