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Medical Devices; US and Chinese legislation

US and Chinese legislation US legislation What is the framework of US Legislation? Figure 1: Framework of FDA Legislation. Adapted from FDA Legislation. Copyright 2020, Kvalito Consulting Group.   How to classify a device under US regulation? Picture from...

Risk Management for Medical Devices: ISO 14971:2019

What types of risks are covered by Risk management? It covers the harms related to patients, users or/and environment. What is the difference between Design controls and Risk management? Design Controls prove that the Medical Device is safe, effective and meets the...

Vigilance from a Medical Device Perspective

What is Vigilance? It is a system for the notification and evaluation of incidents and Field Safety Corrective Actions (FSCA) involving Medical Devices. (MEDDEV 2.12-1, rev.8) What steps shall the manufacturer follow to report an incident? Technical documentation...

Classification of Software as a Medical device under Medical Device Regulation (European Union)

Classification of software as a Medical device under Medical Device Regulation (European Union)  The first step is to determine whether your software is a Medical Device.   How do you determine if...

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