ROHS Compliance: An essential Guideline for Medical Device Manufacturers
RoHS compliance has become a focal point for companies worldwide, shaping their production methods and product design to align with…
FDA Labelling Requirements: An Overview
FDA labelling Requirements
ISO 62366 and Usability Requirements for Medical Device
ISO 62366 plays a fundamental role in the design process for medical device as it explains the requirements related to…
ISO 10993-1 : Biocompatibility Evaluation for Medical Devices
Biocompatibility evaluation according to ISO 10993-1 and the related biological risk assessment is one of the most important validation activities…
New ISO 14155:2020 Clinical Investigation for Medical Devices
Very recently, ISO published a new version of ISO 14155:2020 – Clinical investigation of medical devices for human subjects —…
ISO 15223-1:2021 : New Symbols for Medical Devices
ISO 15223-1:2021 new symbols for medical devices In this paragraph, we will talk about the update of ISO 15223-1 that…
Cybersecurity Requirements for Medical Devices and EU MDR 2017/745
In the last decade, the role of cybersecurity substantially increased in the medical device sector; new guidelines to define cybersecurity…
