Mary Weick-Brady, MSN, RN is President of MedDLI, LLC, a global medical device consulting company for regulatory policy, labeling, adverse event reporting, and complaint handling. Ms. Brady retired from the US Food and Drug Administration's Center for Devices and Radiological Health as a senior policy advisor on post-market regulations, guidance, and international standards. She represented the US on ISO standards for home use, symbols, and infusion pumps. She also represented the FDA on the Global Harmonization Task Force's (GHTF) post-market study group, developing documents for regulatory agencies to use in complaint handling and adverse event reporting, including a standardized coding structure for reporting. Ms. Brady developed the CDRH Home Care Initiative to assure the safety of prescription medical devices being used in the home environment. She worked for the FDA for 25 years and prior to this, worked in numerous clinical settings including home care, ambulatory health care, long-term/hospice care, the Peace Corps, and the Mayo Clinic.