Dear all
We are going to produce a implantable medical device, i want to know if there are any regulation for medical device, i have been reviewing ISO 15883 Part 1, 2 , but i want to know if there are more regulations, or test to satisfy in our process.
Thanks in advance
We are going to produce a implantable medical device, i want to know if there are any regulation for medical device, i have been reviewing ISO 15883 Part 1, 2 , but i want to know if there are more regulations, or test to satisfy in our process.
Thanks in advance