| Possesses Outstanding Expertise in Clinical Statistical Analysis and Medical Device Approval
| Expecting to Contribute Successfully to FDA Approval
JNPMEDI, a company specialized in clinical trial data platforms, introduced on the 3rd, the Director Sooyoung Kwak, who is an expert in FDA approval with outstanding proficiency in medical device regulation and clinical statistical analysis. Through this recruitment, it is expected to further strengthen JNPMEDI’s global clinical competitiveness.
Director Kwak’s academic background has contributed to her development of FDA approval competence, earning her Bachelor’s degrees in Biology from Ohio State University and a Master’s degree in Clinical Statistics from the University of Michigan. In addition to leading numerous projects to success, particularly in the field of medical device approval, she is known for her extensive knowledge and experience. All the products in Lunit INSIGHT (CXR Triage, MMG, DBT), for which she managed statistical analysis, has received FDA approval and played a pivotal role in preparing and analysing FDA approval clinical trials.
The process of FDA approval requires stringent guidelines for verifying products’ safety and efficacy. Especially for the approval of SaMD (Software as a Medical Device) 510(k), it necessitates complex clinical research designs, including Multi-Reader Multi-Case Study and Standalone Study, etc. Director Kwak has played a key role in successfully navigating this complexity.
Additionally, Director Kwak contributed to the Korean Ministry of Food and Drug Safety (MFDS)’s Department of Medical Device Review, where she was in charge of reviewing and developing clinical statistics, as well as approving medical device plans and manufacture/import permits. This experience is expected be a dominant part in supporting JNPMEDI to effectively meet the requirements of stringent authorities such as FDA.
Kwunho Jeong, CEO of JNPMEDI stated, “The FDA approval process is highly demanding, posing challenges to various companies. As Director Kwak joined our team, we are expecting to assist our clients to successfully receive FDA approval and overcome any difficulties”.
| Possesses Outstanding Expertise in Clinical Statistical Analysis and Medical Device Approval
| Expecting to Contribute Successfully to FDA Approval
JNPMEDI, a company specialized in clinical trial data platforms, introduced on the 3rd, the Director Sooyoung Kwak, who is an expert in FDA approval with outstanding proficiency in medical device regulation and clinical statistical analysis. Through this recruitment, it is expected to further strengthen JNPMEDI’s global clinical competitiveness.
Director Kwak’s academic background has contributed to her development of FDA approval competence, earning her Bachelor’s degrees in Biology from Ohio State University and a Master’s degree in Clinical Statistics from the University of Michigan. In addition to leading numerous projects to success, particularly in the field of medical device approval, she is known for her extensive knowledge and experience. All the products in Lunit INSIGHT (CXR Triage, MMG, DBT), for which she managed statistical analysis, has received FDA approval and played a pivotal role in preparing and analysing FDA approval clinical trials.
The process of FDA approval requires stringent guidelines for verifying products’ safety and efficacy. Especially for the approval of SaMD (Software as a Medical Device) 510(k), it necessitates complex clinical research designs, including Multi-Reader Multi-Case Study and Standalone Study, etc. Director Kwak has played a key role in successfully navigating this complexity.
Additionally, Director Kwak contributed to the Korean Ministry of Food and Drug Safety (MFDS)’s Department of Medical Device Review, where she was in charge of reviewing and developing clinical statistics, as well as approving medical device plans and manufacture/import permits. This experience is expected be a dominant part in supporting JNPMEDI to effectively meet the requirements of stringent authorities such as FDA.
Kwunho Jeong, CEO of JNPMEDI stated, “The FDA approval process is highly demanding, posing challenges to various companies. As Director Kwak joined our team, we are expecting to assist our clients to successfully receive FDA approval and overcome any difficulties”.