to MDR documentation, risk management updates, and regulatory alignment-removing this burden from engineering leaders...: MDR & Regulatory Execution Own and produce MDR-required artifacts, including Design History Files (DHF), Technical...
matter expertise, technical guidance, and leadership for the application of health and medical device SW regulatory standards... materials for various regulatory domains including FDA, PMDA, and EU-MDR. Job Duties Advise SW development teams...
matter expertise, technical guidance, and leadership for the application of health and medical device SW regulatory standards... materials for various regulatory domains including FDA, PMDA, and EU-MDR. Job Duties Advise SW development teams...