1.5. Regulatory Compliance
Process of ensuring that a medical device meets all applicable regulations, standards, and guidelines set by regulatory bodies such as the U.S. FDA, European Notified Bodies, etc. These regulations are in place to ensure the safety, efficacy, and quality of medical devices before they reach the market.
A formal plan outlining the recommended strategy for obtaining or verifying regulatory approval to market(s) the proposed product in the designated countries. Depending upon the identified marketing goals, this may include strategies for dealing with the specific requirements of the applicable international regulatory agencies, including applicable national and international regulations and standards.
Determine if there are any other country-specific requirements (e.g. Canada, MDSAP, MDR, etc.)