Tech Etch holds itself to the highest quality standards and follows internationally recognized standards to ensure we provide solutions and services that meet the highest standards possible.
ISO13485 clause 7.3 “Design and development” and its subclauses are excluded from the scope of Tech Etch’s ISO13485 Certification. Products at Tech Etch are manufactured to customers’ design and specifications. Customers are responsible for controlling their product design and evaluating risks associated with those designs.
ISO 13485:2016 | Tech Etch
The 13485:2016 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 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. 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. technical support). ISO 13485:2016 can also be used by suppliers or external parties that provide product, including quality management system-related services to such organizations.
The certification demonstrates the fact that Tech Etch produces components for safe and effective medical devices that meet the regulatory requirements of their customers. 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. Every day Tech Etch is critical in providing solutions against threats and uncertainties that face their company, the United States, and across the globe.
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