In 2003, the International Organization for Standardization (ISO) issued ISO 13485, officially known as EN ISO 13485:2003. This voluntary international standard provides a framework to assist medical [...] Read More
Although medical device manufacturers have to adhere to a number of pertinent regulations to access foreign markets, there are some that stand out amongst the others. ISO 13485 is one such standard, and many firms strive to attain compliance with it.
Why ISO 13485?
For many medical [...] Read More