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EUSSWISSMED is looking for partnerships and clients, who need regulatory compliance support in their • QMS for ISO 13485, • IVDR-, • MDR- and • FDA-filings for • medical devices (class 1-3) and IVD devices (class A-D). We offer • regulatory support in R&D, • clinical studies (all phases) and • MA application (EMA) and • pre-IND preparation (FDA). We support from • EU Representative services, • 510K (FDA), • EUDAMED registration up to • post market surveillance and • PSUR services. We are searching for clients needing to refurbish their • technical documentations of legacy products for • IVDR compliance including updating their QMS respectively. We support • clinical evaluations addressing the requirements of the IVDR / MDR and FDA. Our team of experienced medical officers and MD specialists is ready to start projects short- and long-term.