Synex Consulting Ltd. will offer the FDA Seminar, consultants’ lecture and consultation at ‘KIMES 2018’ which is run from 15th to 18th of March at COEX.
Synex is a consulting firm that helps healthcare companies with market access issues. It helps customers to predict and overcome diverse and complex issues in manufacturing, clinical study, regulatory approval, reimbursement, etc. Synex offers integrated solutions which are carefully designed to achieve both regulation compliance and commercial success. Visit and gain useful insights from Synex at KIMES 2018.
The healthcare business is regulated in multiple layers. Regulatory changes may impact decision-making, time-to-market and the competitive landscape. Especially, regulations on approval and reimbursement listing had diverse changes. Such as new draft guideline on medical device software leveraging Big Data and Artificial Intelligence (AI), ‘Moon Jae-in care’, Introduction UDI system. Therefore, manufacturers and importers need to meticulously plan a strategy for market access in detail. Synex will provide lectures and consultation regarding these issues in a comprehensible level to let visitors approach them easily. It will be a good opportunity to meet with industry’s leading consultants for those who aim to commercialize their products.
At the FDA seminar, Synex will cover how to Prepare FDA 510(k) Notification and QSR Inspection. Synex expects the seminar will help Korean manufactures understand the USA regulation.
Consultants of Synex will share experience and insights at KIMES 2018 on how to address regulatory issues and achieve business goals. It is expected to have lot of visitors, so it is mandatory to secure your time for consultation. For a free consultation, please contact Synex’s marketing team to schedule an appointment.
Meanwhile, KIMES 2018 is the biggest international medical and hospital equipment exhibition of Korea. KIMES sets the stage for introduction of latest tools and technology that may aid in the healthcare industry etc. in the Hospitals and Medical Equipments industry.