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FDA Final Rule: ISO 13485 Now Central to U.S. Medical Device QMS – Are You Fully Aligned?

What SME Manufacturers Need to Know—and How QNET Can Support You The U.S. Food and Drug Administration (FDA) finalized its Quality Management System Regulation (QMSR), marking the most significant overhaul of U.S. medical device quality system requirements in over two decades. The new regulation formally integrates ISO 13485:2016 into 21…

Swiss Medtech Sector Faces Uncertainty Amid U.S. Tariff Changes – Swiss Medtech and CH-REPs Call for Diplomatic and Regulatory Action

April 12, 2025 – The Swiss medical technology industry faces growing uncertainty following the U.S. government's recent decision to impose import tariffs on countries with trade surpluses. With a considerable surplus, Switzerland has been hit with a 31% tariff—significantly higher than many other nations. This move directly threatens the Swiss…

Heightened Scrutiny on EU Post-Market Surveillance (PMS) Requirements by Dutch Health Authority

April 2025 – European Union Post-Market Surveillance (PMS) is a cornerstone of the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR), requiring all manufacturers to continuously monitor the performance and safety of their devices once on the market. However, recent inspections by the Dutch Health…

General Product Safety Regulation (GPSR 2023/988) Explained | QNET BV

Introduction The European Union has adopted the General Product Safety Regulation (GPSR) 2023/988, which replaces the previous General Product Safety Directive (GPSD 2001/95/EC). The GPSR introduces stricter safety requirements and modernized rules to ensure that all products on the EU market are safe, particularly addressing challenges posed by online sales,…

Navigating the EU AI Act Regulation 2024/1689: Impacts on Medical Device Software (MDSW)

The EU AI Act: How It's Transforming AI in Healthcare and Medical Devices The EU AI Act (Regulation 2024/1689) is a groundbreaking legislation governing artificial intelligence (AI) systems across the European Union. As its first comprehensive regulatory framework, the Act has profound implications for AI, particularly in healthcare and medical…

Post-Market Surveillance (PMS): Ensuring Compliance Across the EU, UK, and Switzerland Requirements

Executive Summary PMS is a regulatory requirement that systematically monitors a medical device's safety, performance, and quality once it enters the market. PMS processes allow manufacturers to collect real-world data, assess device efficacy, and ensure long-term compliance with regulatory standards. QNET, as your Authorized representative in the EU, UK, and…

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