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Tag: ISO 13485

Sequana Medical announces 2023 Full Year Results and 2024 Outlook | BioSpace

PRESS RELEASEREGULATED INFORMATION – INSIDE INFORMATION28 March 2024, 08:00 a.m. CET alfapump® – PMA1 submitted to US FDA and accepted for substantive review, extensive feedback...

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ISO 27001 Vulnerability Assessment – QualityMedDev

In the intricate realm of information security, where digital landscapes evolve and cyber threats loom large, the ISO 27001 standard stands as a beacon...

ISO 27001 Vulnerability Assessment – 4EasyReg

In the intricate realm of information security, where digital landscapes evolve and cyber threats loom large, the ISO 27001 standard stands as a beacon...

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 organizations toward robust cybersecurity...

Asset Management according to ISO 27001:2022 – QualityMedDev

In the complex landscape of information security, where data reigns supreme, the ISO 27001 standard stands as a beacon guiding organizations toward robust cybersecurity...

Asset Management according to ISO 27001:2022 – 4EasyReg

In the complex landscape of information security, where data reigns supreme, the ISO 27001 standard stands as a beacon guiding organizations toward robust cybersecurity...

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, ensuring that they are...

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 suitable Business Continuity Plan...

Nanoflex Robotics Receives ISO 13485 CertificationThe innovative medical robotic startup achieved the globally recognized ISO 13485 certification in December 2023 | BioSpace

ZURICH, Switzerland, Jan. 10, 2024 (GLOBE NEWSWIRE) -- Nanoflex Robotics AG, a remote robotic surgical company based in Switzerland, has received the internationally recognized...

Packaging Complaint Investigation – Case Study

This is part one of a case study on how to perform a packaging complaint investigation when packaging is found open by a customer. Overview...

Our Top 10 Medical Device Videos of 2023

The number of StarFish Medical YouTube subscribers grew by 32% in 2023 and social media views increased an amazing 100%. This round-up features the...

Pixium Vision announces the 48-Month Trial Results in Severe Atrophic AMD | BioSpace

Pixium Vision announces the 48-Month Trial Results in Severe Atrophic AMD Study confirms subretinal prothesis feasible and well-tolerated with no reduction of natural...

AliveDx secures IVDR certification for sites in UK and Switzerland

Switzerland-based vitro diagnostic company AliveDx has announced it received an In Vitro Diagnostic Regulation...

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