Customer Related Process according to ISO 13485
The requirements for customer related process are reported in the section 7.2 of the ISO 13485:2016. Customer related processes are highly linked with other processes of the quality system, such
Gamma Sterilization Process for Medical Devices
Gamma sterilization is extensively used in the life science sector and more specifically in the medical device sector, where gamma radiation plays a fundamental role as technique for product sterilization. Gamma
Strategy for Regulatory Compliance according to EU MDR 2017/745
Having a Strategy for Regulatory Compliance is a new requirements clearly mentioned in the European Medical Device Regulation (EU MDR 2017/745) and EU IVDR 2017/746 (European In Vitro Diagnostic Regulation).
