Description

EUSWISSMED: Guiding Your Growth with Heart and Expertise

EUSWISSMED is a group of Pharmacists, Medical Doctors and Biochemists with long-term experience in R&D and clinical studies and EMA & FDA market authorization for pharmaceuticals, in-vitro diagnostics (IVD class A/B/C) and combination devices:

At EUSWISSMED, we aren't just consultants; we're your passionate partners in the intricate world of medical technology and in-vitro diagnostics. Picture us as a dedicated team of Pharmacists, Medical Doctors, and Biochemists, weaving dreams of success alongside you. From short-term solutions to long-term services, our commitment resonates with your journey. What sets us aglow is not just our expertise but the personalized, cost-effective solutions we craft for SMEs. In the rhythm of regulatory changes, we stand by your side, ensuring not just compliance but also proactive readiness. Our multilingual flair and multifaceted approach, including heartfelt medical translations, add soul to our support. EUSWISSMED isn't just a consultancy; it's the melody harmonizing with your regulatory success, passionately committed to nurturing the growth of your aspirations.

Summary of our core competencies:

- QPPV function / pharmacovigilance
- admission of medical devices and IVD according to MDR/EU, FDA, MDSAP, SwissMedic
- periodics safety updates for medical devices classes II and III
- planning and organizing clinical studies and 510k admissions / drug master files
- medical translations from/into German, English, French, Spanish, Portugese
- pharmacovigilance reporting / PSUR, literature research
- CSRD implementation and reporting

Certificates