1. Kor /
  2. Eng

  1. Kor /
  2. Eng

Faulty List At SAIHST, we have faculties from various backgrounds such as ; basic science, clinical medicine, pharmacology, engineering, business etc. SAIHST is always open for future competent faculties to lead biomedical science.

Bumsun Kang / Engineering M.D.
Name : Bumsun Kang  Engineering M.D. Department : MDLab, Inc. Title : Technical Director Campus : Office : E-mail : bs.kang@mdlab.co.kr Homepage : Lab. title : Related Department : Department of Medical Device Management and Research Print PDF Download
■ Careers

2000 Engineering Bachelor, Dep. of Electrical engineering, Kunkuk University 
2014 Engineering M.D., Dep. of Electronic engineering, University of Seoul
2001 - 2013 KTL, Director of Test and evaluate medical devices for international certifications
2013 - Present MDLab, Inc., Technical Director 
2013 - Present MFDS SC62A Expert committee member
2013 - Present IEC TC62/SC62A/WG14 member


■ Research Interest

Korea and other countries have a stringent regulatory approval process for medical devices, because medical electrical equipment may cause serious risk to patients due to leakage of electricity, electromagnetic disturbances, biological safety and use errors, etc. The core of the regulatory approval process is to ensure that medical electrical equipment have been designed and manufactured in accordance with the international standards. To this end, The International Electrotechnical Commission (IEC) and the International Organization for Standardization (ISO) have established international standards that define medical electrical equipment safety requirements. To enhance product competitiveness, products should be developed and verified according to the international standards. Currently, the international standard for medical electrical equipment is IEC 60601 series. IEC 60601 series covers requirements for medical electrical equipment in general, including electrical isolation, overtemperature, risk management, software validation, and usability. However, it is not easy to understand the standards and apply them to products correctly, medical device manufacturers are often experience delays in the product development process due to frequent mistakes and changes and are experiencing difficulties in testing and approval process. This course focuses on understanding the requirements of international standards for medical electrical equipment and applying them correctly to products. Please use this course to develop your expertise in international standards.

■ Research Area

IEC 60601, Medical device standard, Risk management, Software validation, Usability.

■ Major Research Projects 

1. Medical device usability evaluation support Project, 2017 (Korea health industry development institute)

2. Economic cooperating industry development business project, 2017 (Ministry of trade, industry and energy)

3. Medical device- Essential performance guidance, 2017 (Ministry of food and drug safety)

4. The safety and essential performance guideline of nerve and muscle stimulators according to the IEC 60601 Ed.3 particular standard, 2016 (Ministry of food and drug safety)

5. Medical device usability technical support system, 2016 (Seoul national university bundang hospital)

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