Table 2.

Example of some of the quality management system established in the industry to control the quality, reproducibility and safety of the medical product used for human

Program	Definition	Examples	Standard in academic setting	Ref
GLP	A quality system to control reliability, uniformity, reproducibility, quality, and integrity of the processes related to products in development for human or animal health	US: 21CFR58 EU: Directive 2004/10/EC EU: Directive 2004/9/EC	No	26
GMP	Quality assurance and testing guidelines for the manufacture of products related to the health and safety of human to ensure batch to batch consistently, quality, and safety	National regulatory agencies	No	27
ISO 17025	The main ISO standard used by testing and calibration laboratories to ensure valid results	Several, multidisciplinary accreditation bodies are involved depends on the countries	No	28
QSR or ISO 13485	The quality system mandate for all medical device manufacturers in the USA or EU to ensure safety and performance	US: 21 CFR Part 820 EU: ISO 13485	No	29–30