Introduction To The FDA eSTAR ProgramThe medical device industry is witnessing a significant transformation in regulatory affairs, particularly in how manufacturers submit their applications to the US Food and Drug Administration (FDA). The Electronic Submission Template And Resource (eSTAR) program represents the FDA’s commitment to modernizing the review process for medical devices, moving away from…

Leveraging EU MDR CE Marking for Global Medical Device Market AccessA comprehensive guide to maximizing your regulatory strategy through EU MDR complianceIntroductionNavigating the complex landscape of medical device regulatory affairs can be challenging for manufacturers seeking global market access. While many companies view regulatory compliance as merely a hurdle to overcome, strategic manufacturers recognize that…

The Evolving Landscape of European Medical Device Regulatory Affairs: Navigating EU MDR 2017/745 RequirementsFor professionals in regulatory affairs or innovative MedTech companies, understanding the European Medical Device Regulation (MDR 2017/745) represents a critical competency in today’s global healthcare market. The implementation of the EU MDR marked a significant shift from the previous Medical Device Directives…