In the dynamic realm of medical device development, the journey from conceptualization to market availability is intricate and demands meticulous evaluation at various stages. This text explains the processes of pre-clinical and clinical evaluations, essential components in ensuring the safety, performance, and regulatory compliance of medical devices.
From May 2021, new European rules for medical devices (MDR) will apply. The MDR has major impact on the medical sector. It will bring great benefit, but also great challenges for all economic operators involved.
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Artificial Intelligence (AI)-based software medical devices are revolutionizing the healthcare sector in diagnosis, treatment, and patient management. AI-powered Software as a Medical Device (SaMD) and Software in a Medical Device (SiMD) applications cover a wide range of solutions, from medical decision support systems to patient monitoring tools.
The rules for placing medical devices on the Great Britain (GB) and Northern Ireland (NI) markets differ primarily in terms of the timelines and regulatory frameworks
Registration of certain medical devices which are reusable Class I devices, upclassified Class I devices, and/or reliant on expired/expiring CE certificates in Great Britain (GB) and Northern Ireland (NI).
To register medical devices with the MHRA, manufacturers must follow specific requirements and procedures. In this article you will find the key steps and requirements.
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