This course will focus on 4 key elements
1. Basic medical technology
2. Medical device regulatory fundamental e.g. key definition, product classification
3. Regulatory systems in key countries e.g. US, EU, China, SEA including Singapore
4. Key regulatory standards e.g. ISO 13485 and ISO 109993
Programme: BIE(CBE)
This course will focus on 4 key elements 1. Basic medical technology 2. Medical device regulatory fundamental e.g. key definition, product classification 3. Regulatory systems in key countries e.g. US, EU, China, SEA including Singapore 4. Key regulatory standards e.g. ISO 13485 and ISO 109993