After reading through ISO13485, it seems that a point to be aware of is new or revised regulatory requirements. I'm looking for input. How does your company keep track of "new or revised regulatory requirements"? (As of right now, the medical devices are only being distributed in the U.S. but that will most likely expand to other countries in the near future.)
I'm aware that different countries have different regulatory requirements and it depends on where you market your medical device. I'm also aware a person could spend days and weeks on the internet searching for such information. I'm just trying to get an idea of what methods of tracking are being peformed so I can take a semi-proactive response to the situation as opposed to waiting for the results of a regualtory audit.
I'm aware that different countries have different regulatory requirements and it depends on where you market your medical device. I'm also aware a person could spend days and weeks on the internet searching for such information. I'm just trying to get an idea of what methods of tracking are being peformed so I can take a semi-proactive response to the situation as opposed to waiting for the results of a regualtory audit.