Quality management and US regulatory auditing guidelines for medical device manufacturers

What Are the Success Factors for a Partnership with Global Medical Device Companies? Evidence from Korea

“…The medical device industry in Korea continues its significant growth but is still faced with several challenges associated with the characteristics of the industry. In 2019, the Korean medical device market was worth $6.6 billion and was the ninth largest market in the world [32]. Though its market size is ranked relatively high, the Korean medical device market takes up only a 1.6% share of the global medical device market [32,33].…”

“…In 2019, the Korean medical device market was worth $6.6 billion and was the ninth largest market in the world [32]. Though its market size is ranked relatively high, the Korean medical device market takes up only a 1.6% share of the global medical device market [32,33]. On top of the size of the market, the fact that there is no Korean medical device company among the world's leading players also explains why Korea is a catching-up country in terms of the advancement of the medical device industry [12].…”

“…In an effort to seek consistency among regulatory bodies across the world, the Medical Device Single Audit Program (hereafter, MDSAP) was implemented by an alliance of five regulatory partners (Australia, Brazil, Canada, Japan, and the US). As the program meets the regulatory needs of the participating countries, it can significantly reduce the burden of multiple inspections by producing a harmonized single audit [32]. Lastly, the sub-category of cyber-security is selected due to the increasing emphasis on the prevention of cyber-attacks against connected medical devices, especially against personal medical devices [53].…”