Congenius AG Switzerland ce marking, design history file, fda submissions, iso 13485, medtech consulting, process validation, and regulatory affairs
confinis ag Switzerland ce marking, design controls, fda submissions, iso 13485, ivdr, regulatory affairs, risk management, and samd
Scandinavian Regulatory Services AB Sweden ce marking, combination products, fda registration, iso 13485, ivdr, mdr, regulatory affairs, and risk management
GBA Key2Compliance AB Sweden ce marking, fda 510(k), iso 13485, ivdr, mdr compliance, medical devices, regulatory affairs, and technical documentation
Thema S.r.l. Italy ce marking mdr, fda 510(k), iso 13485, iso 14971, ivdr, medical devices, qms consulting, and regulatory affairs
Johner Institut GmbH Germany ce marking, fda approval, iec 60601-1, iec 62304, iso 13485, mdr compliance, medical devices, and regulatory affairs