We are medical device software company that manufactures stand alone software. Our headquarters is ISO 13485 certified and is audited annually by our notified body. We wanted to open another facility in the US where we would only be using that facility for Research and Development, not manufacturing. There would only be engineers that would be writing some code for new products. Should this new facility comply with ISO 13485 if we are not manufacturing there? Should our notified body be able to audit that facility? Can anyone point to the standard for any support? Thank you in advance for your help.