This document aims to provide guidance on different aspects related to standards in the medical devices sector in support of the requirements laid down in the applicable EU legislation, taking into account its specificities
News & Trends
Procurar
Recentes
- EU MDR Update: New Harmonised Standards for Medical Devices
- Clinical evidence for orphan in vitro diagnostic medical devices
- Questions and answers for marketing authorisation holders/applicants referral on nitrosamine impurities in human medicinal products
- TEAM NB Code of Conduct for Notified Bodies vs 5.3
- GIRP POSITION PAPER: Revision of the EU Guidelines on Good Distribution Practice for Medicinal Products for Human Use
- New guidance document MDCG 2026-6 on Guidance on clinical evidence for orphan IVDs
- AI in pharmacovigilance – EMA update
- Formação ESTUDOS DE ESTABILIDADE . New ICH Q1 Guideline changes: ” Formação bastante abragente e de alto valor técnico”