cardiogram

MFDS guidelines ECG HF stimulation

Korean MFDS guidelines ECG HF stimulation was recently published (June 12, 2015) in order to help completion of

Korean MFDS guidelines ECG HF stimulation was recently published (June 12, 2015) in order to help completion of medical device license and technical documentation. The products covered are high frequency stimulation and electrocardiograph.
The guidelines describe a variety of high-frequency stimulation of different properties/techniques as well as electrocardiographs. The structure of the guideline is such that a lot of examples can be found with detailed requirements for documentation.
The links can be found below (in Korean):
high-frequency stimulation
electrocardiographs

 

 


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About nicolas

My name is Nicolas Clary, I'm the founder and CEO of Kobridge Consulting Ltd. in 2006 when I met my wife in Korea I had no idea it would lead me to this. At that time I was already a consultant and regulatory expert for Medtech companies. I was also an auditor for the French Notified Body LNE. In 2007 I decided to move to Korea to establish a consulting business there. At first I was like most my actual clients : completely lost. It took me a lot of time to understand all the regulatory processes in Korea and fortunately I was lucky enough to find the right people. I am much better now at understanding my clients' needs because I've been in their shoes before. I usually say that I'm a translator. Understanding different regulations helps to explain certain requirements (here Korea vs Europe or US). I can also translate the needs of regulatory professionals to sales professionals and vice versa.