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Marion Lepmets
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,...
Marion Lepmets
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...
Matteo Gubellini
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....
Marion Lepmets
Keeping your data safe is vital for every business. One way to do this is by following ISO 27001. But how can we manage these information security risks with a tool like Jira? Let’s dive in! What is Information Security Risk Management Information Security Risk Management is all about identifying,...
Marion Lepmets
Integrating risk management into the Software Development Lifecycle (SDLC) of a product is crucial to its success. It enhances the safety, security and reliability of your software product. When you identify, assess, and mitigate risks early, you can avoid bigger problems down the line. Think of it as a systematic...
Marion Lepmets
If your team is working in Jira and you need to conduct hazard analysis, you can do so using the SoftComply Risk Manager Plus app. Hazard analysis is crucial in safety-critical product development, especially for medical devices. If you prefer to watch the video instead of reading, you can do...
