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What Is Regulatory Affairs in Medical Devices: The Ultimate No Nonsense Guide
IntroductionIn the complex world of medical device development and commercialization, regulatory affairs plays a pivotal role in ensuring products are safe, effective, and compliant with global requirements. What is regulatory affairs in the medical device industry? At its core, regulatory affairs is the profession responsible for navigating the intricate web of regulations governing medical devices…
FDA eSTAR: Navigating the New Era of Medical Device Submissions
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 Approvals and Market Access with CE-Marking
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…
Technical documentation under the EU MDR
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…