Tag Archives: iec 62366-2

IEC 62366 – Usability Engineering for Medical Devices

10 February 2021 0 Comments

Standards are necessary for the better functioning and regulation of different manufacturing and industrial sectors. And when it comes to the healthcare sector, their importance increases to a thousand folds. IEC 62366 is also one of such standards. Devised by IEC, this standard is divided into two parts. Part one of this standard aims to […]
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Decoding EU MDR Requirements on Human Factors Engineering (HFE)

18 April 2020 Comments are off

As many clients and professionals are trying to understand the new requirements of European Union’s Medical Device Regulations (MDR) on Human Factor Engineering (HFE) and usability engineering. This blog tries to address some queries with proper explanation and guidance. But before we actually begin, let us offer you a brief insight of what Human Factor […]
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Quality & Regulatory Blog

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