Simbex maintains a Quality Management System which is compliant to ISO 13485 and the FDA’s Quality System Regulation 21 CFR 820 for the development of medical devices.
Our experienced engineering staff has developed products and devices for many industry leading companies and will provide a detailed Design History File, Device Master Record, and complete Risk Analysis compliant to ISO 14971 that will meet your specific regulatory requirements.
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We are committed to continuously improving the quality of our work, the excellence of our service and the value we create for our customers and our staff. Our quality system is in place to ensure that our people, practices, systems and culture work together to create quality and value.
Simbex Advisor and Founder
