We are a contracted manufacturing company we design nothing. We make medical tubing to customer drawings only. The company is wanting to possibly design there own custom medical tubing and become the end user. The question has come up wanting to know what steps would have to be taken when it comes to regulation can we stay just certified to ISO 13485:2016 and will this open the door to be audit by FDA and what other regulators would the company be subjected to. Any guidance would greatly be appreciated.