ISO 14971 : Risk Management for Medical Devices
The approval of ISO 14971 for medical device risk management in December 2019 marked a significant milestone in ensuring the…
ISO 27001 Vulnerability Assessment
In the intricate realm of information security, where digital landscapes evolve and cyber threats loom large, the ISO 27001 standard…
Asset Management according to ISO 27001:2022
In the complex landscape of information security, where data reigns supreme, the ISO 27001 standard stands as a beacon guiding…
Cybersecurity Threat Model Implementation: FDA Requirements
The Food and Drug Administration (FDA) plays a pivotal role in safeguarding public health through the regulation of medical devices,…
Business Continuity Plan: Strategies for Implementation
As the digital era continues to expand, information security stands as a cornerstone of modern business strategy and having a…
Medical Device Lifetime: An Overview
The Integral Role of Lifetime in Medical Device Utilization The lifetime of a medical device is a critical period during…
MDR Extension According to Regulation 2023/607
The extension of MDR implementation timeline has now become reality. On March 20, 2023, the Regulation (EU) 2023/607, which amends…
Article 61 of EU MDR: An Overview
In this post, we will delve into the key requirements outlined in Article 61 of EU MDR 2017/745, which pertains…
Reprocess of Single Use Devices: EU MDR Requirements
Article 17 of the EU MDR 2017/745 provides comprehensive guidelines regarding the requirements for the reprocessing of single-use devices. The…
ISO 17511: Metrological Traceability for IVD Medical Devices
Recently, a new version of ISO 17511 has been published, bringing forth updated requirements for ensuring metrological traceability in In-vitro…
