In addition to the Atlassian’s concession program that provides financial relief to the Ukrainian customers, we at SoftComply will offer our apps for free to all companies offering humanitarian aid to those affected by the war in Ukraine.
Should your company be one of the many providing humanitarian aid in the region of the conflict or to those affected by it, please don’t hesitate to reach out to us for free usage of our apps.
By Marion on 11 Mar 2022
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The Role of Cybersecurity in Medical Device Safety The Global medical device market is a $800 billion business that is rapidly growing, especially in the area of software as a medical device (SaMD). The majority of the SaMD segment is made up of the digital health and digital therapeutics solutions,...
Introduction This medical device compliance guide focuses on the key requirements and strategies for navigating the regulatory landscape. We will cover the role of major regulatory bodies like the FDA, the classification of devices, and the importance of quality management. We will also discuss the challenges of global compliance and...
This case study describes the experience of a multinational medical device manufacturer meeting the FDA cybersecurity requirements. The company is operating in the MedTech sector developing a class 2/IIb device consisting of hardware and software. The company spent about 2 years working on the security risk management of the device....
