List of Contributions

Hi, Can someone please provide guidance for setting up a Non-Sterile Clean Room Sampling booth/standard? I am only finding clean room standards with microbiological limits for biological and sterile products. Is their a clean room requirement for non-sterile medical devices? Simply, trying to figure ...

Hello, Does anyone know the pros and cons / gap analysis of being audited for ISO 13485:2016? Currently we use ISO 13485:2003/EN ISO 13485:2012. Thanks. ------------------------------ Zain ------------------------------