Custom Surgical GmbH is a medical devices manufacturer registered in EUDAMED and the FDA.Custom Surgical GmbH has put in place a certified quality management system in accordance with the standards DIN EN ISO 9001:2015. In addition, the system meets the requirements of the European Medical Devices Regulation and Good Manufacturing Practices (GMP).
Custom Surgical GmbH places a strong emphasis on ensuring the safety of their products. To ensure product quality, they use only components that have demonstrated reliability and safety. They work closely with accredited inspection offices to conduct detailed testing and obtain certifications for their products. The manufacturing and testing processes for their products are dependable, efficient, and continuously monitored.
Furthermore, each production process is followed by safety testing using specialized testing systems, and the outcomes are meticulously recorded. As a result, each product is uniquely identified and certified before it is delivered


FDA Establishment Registration & Device Listing - Custom Surgical GMBH
FDA Establishment Registration & Device Listing - MicroREC
English - ISO 9001:2015 Quality Management System
German - ISO 9001:2015 Quality Management System
MicroREC - Medical Device Class A according to Health Science Authority from Singapore