Compliance and Certification

Friedrich Daniels is proud to be an FDA-registered and approved prototype and production facility, adhering to the highest regulatory standards for the manufacturing of custom surgical instruments. Our commitment to safety, quality, and precision ensures that every instrument we produce meets stringent guidelines set forth by the U.S. Food and Drug Administration (FDA), providing our clients with confidence in the reliability and performance of their medical devices.

In addition to FDA registration, Friedrich Daniels is ISO 13485:2016 certified, demonstrating our dedication to quality management systems specifically tailored for the medical device industry. This international certification underscores our focus on maintaining consistent processes, ensuring product traceability, and delivering solutions that meet both regulatory and customer requirements. By continuously monitoring and improving our processes, we remain committed to advancing innovation while prioritizing the safety and well-being of healthcare professionals and patients worldwide.