January 20, 2025Demonstrates compliance with internationally recognized quality management system standards, ensuring consistent product and service quality.- January 20, 2025Specifies requirements for a quality management system in the design, production, and distribution of medical devices, ensuring regulatory compliance and…
- January 20, 2025Indicates adherence to the FDA's Quality System Regulation (QSR) for medical device manufacturing, ensuring products meet safety and efficacy requirements.
- January 20, 2025Certifies authorisation to manufacture, repackage, and relabel medical devices in compliance with regulatory standards.
- January 20, 2025Ensures compliance with country-specific medical device regulations across the EU, European Economic Area (EEA), and Switzerland.
- January 20, 2025Confirms conformity with the European Union’s Medical Devices Directive (MDD), allowing legal market access in the EU.
- January 20, 2025Demonstrates adherence to the Waste Electrical and Electronic Equipment (WEEE) Directive, ensuring responsible disposal and recycling of electronic medical devices.