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…
RoHS compliance has become a focal point for companies worldwide, shaping their production methods and product design to align with…
FDA labelling Requirements
ISO 62366 plays a fundamental role in the design process for medical device as it explains the requirements related to…
Biocompatibility evaluation according to ISO 10993-1 and the related biological risk assessment is one of the most important validation activities…
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 In this paragraph, we will talk about the update of ISO 15223-1 that…
Introduction: Cybersecurity Requirements and EU MDR 2017/745 In the last decade, the role of cybersecurity substantially increased in the medical…
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