The new MedTech regulatory environment in Europe is providing exciting new opportunities for the evolution of the Medical Affairs function, bringing much value to medical device companies. European Regulators are asking for greater effort from the industry in generating and communicating clinical evidence on efficacy and safety of their medical devices, diagnostics and drug-device combinations. All this combined with increasing quality standards make a strong case for a lead role for medical affairs in pre- and post-market processes. As medical affairs is transforming into a strategic business function, the medical device industry will prove to be an exciting one for medical affairs professionals. Download the full article here.
(Source: Dias J, et al. A Compelling Strategic Role for Medical Affairs in the Context of New EU MedTech Regulations)