State-of-the-Art (SOTA) in MDR 2017/745
A Whitepaper on Best Practices and Compliance Executive SummaryState-of-the-Art (SOTA) is a cornerstone concept within the EU Medical Device Regulation (MDR) 2017/745. Although the regulation does not define the term explicitly, it is referenced extensively in guidance documents and regulatory assessments. SOTA serves as the benchmark for technological, clinical, and risk management expectations in the […]
Challenges in Post-Market Surveillance
Insights from IGJ and Swissmedic Report In the medical device industry, maintaining product safety and performance long after market introduction is crucial. Post-market surveillance (PMS) plays a pivotal role in ensuring devices continue to meet regulatory standards, particularly under the MDR, which also forms the foundation for the PMS requirements set out in the Medical […]
Top Management Responsibilities in Medical Device Companies: The Heart of a Quality Culture
In the medical device industry, where human lives could depend on product safety and effectiveness, the commitment of top management to quality cannot be overstated. Their role is central to building a successful quality culture that fosters compliance with regulatory requirements, customer satisfaction, and maintaining an effective Quality Management System (QMS). Clause 5 of ISO […]