Certifications

Your satisfaction is always at the heart of everything we do,ISO Certifications Help Us To Achieve Customer Satisfaction.

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Prototyping & Manufacturing

Our certifications

Xtmade is certified and compliant with ISO 9001:2015, ISO 45001:2018 and ISO 14001: 2015. These ISO standards specify the management requirements for quality, occupational health and safety and environmental protection. They demonstrate our commitment to consistently providing you with high-quality prototyping, volume production and related services.
Our most recent certification is ISO 13485: 2016, which specifically regards the quality system for medical device manufacturing and other health-related services.
These management systems, along with our advanced inspection, measuring and testing equipment, ensure you will always receive products that meet and exceed your expectations.

ISO 13485: 2016

Get your medical product to market quickly, Xtmade is committed to being a provider of custom parts manufacturing solutions for medical product developers. Our ISO 13485:2016 certification gives you peace of mind that our raw materials, testing, inspection, and production processes adhere to the strict quality control guidelines required for regulatory approval. This will help you when you are ready to submit your product to the FDA or EMA for classification.

ISO 9001: 2015

Exceeding your quality expectations, we received our ISO:9001 certificate in 2024 and have been continuously improving our systems since then. ISO standardized manufacturing helps us stay ahead of the curve. ISO:9001 is one of the management systems that establishes standardization, documentation, and consistency as the keys to controlling the quality of finished products.

ISO 45001: 2018

Reducing Risks to Control Your Costs,The ISO 45001: 2018 Occupational Health and Safety Standard helps us analyze risk factors in our business and then lays out a strategy to mitigate or eliminate those risks to prevent downtime and costly injuries.

ISO 14001: 2015

Reducing Waste Means Increasing Efficiency,Protecting the environment is every bit as important as protecting the safety of the workforce. Under the guidelines of ISO 14001:2015, we’ve established an environmental management system that follows the discipline of Plan-Do-Check-Act for continual improvement.