According to this announcement within the thread ISO 13485 is a critical step for CE clearance and TGA certification. Since this announcement took place harmonization has also taken effect within Canada, Japan and also the United States is set align previous standards to ISO 13485. It looks like since RAP has this accreditation it holds a huge advantage in helping it obtaining FDA clearance, we are already ahead of the game!
"FDA intends to harmonize and modernize the Quality System regulation for medical devices. The revisions will supplant the existing requirements with the specifications of an international consensus standard for medical device manufacture, ISO 13485:2016. The revisions are intended to reduce compliance and recordkeeping burdens on device manufacturers by harmonizing domestic and international requirements. The revisions will also modernize the regulation."
"Since medical device regulators in the EU, Japan, Canada, and Australia, among others, base their quality system requirements on ISO 13485:2016, FDA can utilize this opportunity to modernize the regulation to align with a more internationally accepted quality system standard."
