Overcoming MedTech Challenge #5: Varying and Restrictive Regulations

According to Axendia, regulatory compliance continues to constrain improvement in MD&D manufacturing efficiency and productivity. “Our primary research shows that medical device companies list regulators/government agencies as the top business disruptor,” says Daniel R. Matlis, president of Axendia. The United States Food and Drug Administration (US FDA) and the new European Union Medical Device Regulations…