Regulatory Environment Part A
Regulations are dynamic. In other words, they are in a constant state of flux. It’s the responsibility of each company to ensure their products are in compliance with international, federal, state, and local regulations. This two-part series seeks to highlight some of the more prominent points associated with the multiple facets of regulations impacting the MedTech & BioTech company. Part A addresses topics such as regulatory oversight, the FDA background, class, category and code processes, preclinical research and global aspects of regulatory influence.