SMART quality & compliance
What is the development lifecycle of a Medical Device?
What is the development lifecycle of a Medical Device? First and foremost, the user requirements need to be defined by the organization. Based on the fact that the design and development of the Medical Device can be planned, inputs are implemented and tested, which lead to outputs. The design and development process is then verified, and if needed, some inputs can be added (related to the outputs). The whole process is validated; the CE marking must be accepted before transferring the design and development to production and commercialization. The entire lifecycle is continually controlled. Risk management must be included in…
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SMART quality & compliance
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? How to classify a device under US regulation? In the USA, there are 1700 generic groups of devices classified within 16 medical specialties (21 CFR 862-892). The classification is based on a risk approach. Medical devices classified as Class I are considered as having the lower risk, Class II is considered a moderate risk and class III is the higher risk. How are the…
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SMART quality & compliance
Bite-sized Knowledge: Medical Device Regulation
2A Regulation shall be applied in its integrality in all the European Union. Unless a Directive is an objective provided by the European Union, each country is free to develop its own measures to achieve this objective. Figure 1: Overview of the difference between Direction and Regulation. Adapted from European Law. Copyright 2020, Kvalito Consulting Group. Citizens and Companies implement their policy (act) according to their National law which is an interpretation of the European law. Citizens and companies implement their policy (act) according to European law. What are the changes in Medical Devices regulation? The European Parliament has…
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