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).
ISO 10993 Cytotoxicity Evaluation of Medical Devices
The evaluation of the cytotoxicity of a medical device based on ISO 10993 is one of the key milestone for the introduction of new devices on the market, thus
The role of management representative according to ISO 13485
Introduction In this post, we will go through the main requirements associated with the management representative role taking into consideration one main standard: ISO 13485 - Medical devices — Quality management systems
IEC 60601 – Overview of the Main Requirements
The IEC 60601 has played and still currently plays a key role for safety of active medical devices. The IEC 60601 is basically a group of standards which is dealing
