A
First time poster to this forum.
I am the CEO of a small medical device company. We use a piece of software from an Australian company to design a component of our finished device. This particular device is not currently regulated by the FDA. We are also submitting two 510(K)s for class II devices which are regulated. The AUS company that designed the software uses it similarly and has received NATA endorsed 17025 testing. The National Association of Testing Authorities ( NATA ) is Australia's national laboratory accreditation authority.
The AUS company had the testing done as a part of their ISO13485 certification.
We obviously have to be compliant with 21 CFR Part 820 and Part 11 here in the states. My question is: will the NATA endorsed testing on our software satisfy Part 11 or do we need additional testing/validation....?
I am the CEO of a small medical device company. We use a piece of software from an Australian company to design a component of our finished device. This particular device is not currently regulated by the FDA. We are also submitting two 510(K)s for class II devices which are regulated. The AUS company that designed the software uses it similarly and has received NATA endorsed 17025 testing. The National Association of Testing Authorities ( NATA ) is Australia's national laboratory accreditation authority.
The AUS company had the testing done as a part of their ISO13485 certification.
We obviously have to be compliant with 21 CFR Part 820 and Part 11 here in the states. My question is: will the NATA endorsed testing on our software satisfy Part 11 or do we need additional testing/validation....?