Tag Archives: regulations

asia medical market

Following Trump to Asia

By Ames Gross, President and Founder of Pacific Bridge Medical This article was also published on MedTech Intelligence. A few days after President Trump’s trip to Asia, I made my own business trip to the region. While President Trump hailed his trip as a... Read More

medical software regulation in asia

Medical Software Regulations in Asia 2017

By Ames Gross, President and Founder of Pacific Bridge Medical This article was also published on MedTech Intelligence. Medical software has emerged as a significant gray area in the medical regulatory landscape. Traditionally, most medical software products have been marketed in conjunction with other... Read More

asia R&D growth

Staying Competitive Amid Rapid R&D Growth in Asia

By Ames Gross, President and Founder of Pacific Bridge Medical This article was also published on MedTech Intelligence. From 1970 to 2000, the United States, Europe and, to an extent, Japan dominated the medtech research and development (R&D) world. During this time period, the... Read More

china gcp requirements

Chinese Clinical Trials: New GCP Requirements

By Ames Gross, President and Founder of Pacific Bridge Medical This article was also published on MedTech Intelligence. In late 2014, China announced new medical device regulations. One of the most important new regulations stated that all Class II and Class III devices will... Read More