1 |
Euh, Yoonje, and Shin, Wan Seon. 2017. "A Study on International Standard for Classification of Medical Device : Design of Scoring Model (COD) for Risk Measurement." Proceedings of the Annual Spring Conference of the Korean Society for Quality Management, 295-6.
|
2 |
ISO. 2011. "ISO 14155:2011 Clinical Investigation of Medical Devices for Human Subjects - Good Clinical Practice." International Organization for Standardization.
|
3 |
ISO. 2012. "ISO 14971:2012 Medical Devices - Application of Risk Management to Medical Devices." International Organization for Standardization.
|
4 |
ISO. 2015. "ISO 9001:2015 Quality Management Systems - Requirements." International Organization for Standardization.
|
5 |
ISO. 2016. "ISO 13485:2016 Medical Devices - A Practical Guide." International Organization for Standardization.
|
6 |
Jung, Young A. 2015. "Comparative Study of ISO Standards for Infrastructure Development of Medical Device Clinical Investigation." Masters Thesis, Graduate School, Pukyong National University.
|
7 |
Kang, Tae Geon. 2005. "A Study on Construction of Infrastructure for Medical Device Clinical Investigation." Research Report, Korea Health Industry Development Institute.
|
8 |
Kang, Tae Geon. 2006. "Survey and Management Plan for Medical Device Self Quality Control." Research Report, Korea Health Industry Development Institute.
|
9 |
Kim, Jeong Yeon, and Kwon, Kyenghee. 2013. "A Study on the Comparison of Korea GMP with PIC/S GMP for Enhancing International Competency of Medicinal Product Quality." Yakhak Hoeji 57:432-41.
|
10 |
Kim, Young. 2007. "A Study of a Regulatory System for Medical Devices Based on Classification." Research Report, Synex.
|
11 |
Kim, Young-Je. 2009. "A Study on Operation Situation of GMP System of Medical Devices and Their Improvement Method." Masters Thesis, Graduate School of Life Science, Catholic University of Busan.
|
12 |
Kim, Soon Chang. 2007. "The Analysis and Review on the International Standards for Medical Devices." Research Report, Korea Testing Laboratory.
|
13 |
Kwon, Byung Hoon. 2009. "Research on GMP Operation for Small Manufacturer." Research Report, Korea Testing Laboratory.
|
14 |
Lee, Geon Ho. 2004a. "The Study on Improvement of Quality Management Systems for Medical Device Industry." Masters Thesis, Graduate School of Food and Drug Administration, Chung Ang University.
|
15 |
Lee, Kyung-Man, Baek, Nak-Ki, and Seo, Jong-Hyun. 2010. "A Study on the System Improvement Policy According to the Status Analysis of Medical Device Control System in Korea." Journal of Korean Safety Management and Science 12:37-52.
|
16 |
Lee, Seonghee. 2004b. "A Study on Provision Against Global Harmonization of Medical Device Regulation.", Research Report, Korea Health Industry Development Institute.
|
17 |
Na, Sung Soon. 2009. "Medical Appliances Study a GMP Evaluation Management System." Research Report, Korea Testing and Research Institute for Chemical Industry.
|
18 |
Paik, Woo-Hyun. 2015. "The History of Korean GMP." Yakhak Hoeji 59:40-6.
DOI
|
19 |
Yoon, Jihoon, Kim, Young Jin, Jeon, Gye Rok, and Jung, Changmo. 2012. "Risk Management of Dental Implants Based on ISO 14971." Journal of the Korean Society of Safety 27:91-8.
|