QualityMedDev
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QualityMedDev is a Medical Device blog focusing on QMS and regulatory affairs, with a particular attention to newly published regulatory standards and digital medical devices.
QualityMedDev
3M ago
In the intricate realm of information security, where digital landscapes evolve and cyber threats loom...
The post ISO 27001 Vulnerability Assessment appeared first on QualityMedDev ..read more
QualityMedDev
3M ago
In the complex landscape of information security, where data reigns supreme, the ISO 27001 standard...
The post Asset Management according to ISO 27001:2022 appeared first on QualityMedDev ..read more
QualityMedDev
3M ago
The Food and Drug Administration (FDA) plays a pivotal role in safeguarding public health through...
The post Cybersecurity Threat Model Implementation: FDA Requirements appeared first on QualityMedDev ..read more
QualityMedDev
3M ago
As the digital era continues to expand, information security stands as a cornerstone of modern...
The post Business Continuity Plan: Strategies for Implementation appeared first on QualityMedDev ..read more
QualityMedDev
4M ago
The Integral Role of Lifetime in Medical Device Utilization The lifetime of a medical device...
The post Medical Device Lifetime: An Overview appeared first on QualityMedDev ..read more
QualityMedDev
8M ago
The extension of MDR implementation timeline has now become reality. On March 20, 2023, the...
The post MDR Extension Timeline for Implementation appeared first on QualityMedDev ..read more
QualityMedDev
1y ago
This this post we are going to discuss about the main requirements associated to Article...
The post Article 61 of EU MDR: An Overview appeared first on QualityMedDev ..read more
QualityMedDev
1y ago
The requirements related to the reprocessing of single use devices are reported within Article 17...
The post Reprocess of Single Use Devices: EU MDR Requirements appeared first on QualityMedDev ..read more
QualityMedDev
1y ago
ISO 14644 family of standard defines the requirements for cleanroom environment, thus where sterile devices need...
The post ISO 14644 : Requirements for Cleanrooms appeared first on QualityMedDev ..read more
QualityMedDev
1y ago
In this article, we will go through the requirements for Trend Reporting, that are summarized...
The post Trend Reporting According to EU MDR and IVDR appeared first on QualityMedDev ..read more