EU’s NIS2 directive represents a significant step forward in ensuring that medtech companies have the necessary cybersecurity measures in place to protect against malicious security incidents. Compliance with NIS2 requires medtech companies to take a systematic and structured approach to cybersecurity, including implementing risk analysis, security policies, incident management, continuity planning, crisis management, delivery security, measuring the effectiveness of security work and vulnerability reporting.
Stricter cybersecurity requirements for medtech industry
One of the most important aspects of NIS2 compliance is incident management, which requires medtech companies to have a well-organized process in place for detecting, preventing, and responding to incidents related to IT security. This includes having a cybersecurity manager at management level, who is responsible for overseeing the incident management process and ensuring that the company is meeting all of the necessary requirements.
In addition to incident management, NIS2 also requires medtech companies to have a structured approach to risk management. This includes identifying and assessing potential cyber vulnerabilities throughout the product lifecycle, and implementing measures to mitigate these vulnerabilities.
To achieve NIS2 compliance, it is also important for medtech companies to have a continuity plan in place, which outlines the steps that will be taken in the event of a cyber attack or other security incident. This includes having a crisis management plan in place, as well as ensuring that all subcontractors, storage services and data processing are secure.
What is NIS2?
The NIS2 Directive is the EU’s latest network and information security directive aiming to improve collective cybersecurity across the Union, with the goal of improving the resilience and ability to respond to malicious security incidents, both in the public and private sectors, but also in the EU as a whole.
How can Taipuva help?
At Taipuva, we understand the challenges that medtech companies face when it comes to complying with NIS2 and other regulatory frameworks. That’s why we offer solutions such as Siemens Polarion®. It is a powerful platform that helps manage and comply with regulatory frameworks in the medtech industry, and provides traceability across all projects. This ensures that all requirements are met, and it provides a record of the compliance status. We can help you with TARA (Threat Analysis and Risk Assesment), which is a method for identifying and assessing cyber vulnerabilities throughout product life cycle, and allowing you to fix what is required to mitigate these vulnerabilities.
In summary, NIS2 represents a significant shift in the way medtech companies must approach cybersecurity, and it’s crucial that they take a systematic and structured approach to compliance. Taipuva can help companies with the tools, knowledge and experience necessary to meet the new requirements.
Cybersecurity in product development
Ola Larses, Lead Consultant at Taipuva spoke during Polarion Days about how important it is to understand risks by anticipating scenarios to protect product safety. TARA (threat analysis and risk assessment) is a tool for this, and a key factor when analyzing risks of cyberattacks.
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