Every day Tech Etch is critical in providing solutions against threats and uncertainties that face their company, the United States, and across the globe. A table of contents structured identically to that of ISO 13485:2016 itself, allowing easier. Uses examples and cases from real-life based on the author’s many years of experience in quality management. Tech Etch has the privilege of providing components needed for N-95 masks, ventilators, and ultrasound systems which are all used to save lives affected by COVID-19. Features: A pragmatic and down to earth approach towards the reader’s understanding of ISO 13485:2016 standard requirements implementation. The certification demonstrates the fact that Tech Etch produces components for safe and effective medical devices that meet the regulatory requirements of their customers. ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Flex & Rigid-Flex Circuit Tolerances & Properties.Circuit Layer Generation, Drilling & Plating.
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