establish your product vigilance system, including relevant SOPs, contractual and data exchange agreements with suppliers and service providers to assure your compliance with regulatory requirements and setup/maintain vigilance plans for your product (e.g. PSMF)
prepare / maintain your product risk management plan or risk-benefit profile
establish dedicated and validated safety database for the product
register your company and your product with national and international competent authorities and databases (e.g. EV, EUDAMED, DIMDI, etc.)
train all parties involved in your product vigilance system