Description
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
Service Category(s)
Key Service(s)
Life Science Sector
Certificates