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Compliance

Compliance   #

The Compliance section of MyOrbik provides users with a set of self-assessment tools designed to help evaluate how well their products align with industry-specific regulations. These self-assessment questionnaires focus on major compliance frameworks such as CRA, FDA, and NIS2, allowing users to measure their adherence to key regulatory requirements.

Regulatory Frameworks and Self-Assessment Tools #

 

  • CRA (Cybersecurity Resilience Act):
    The CRA focuses on strengthening the cybersecurity resilience of critical infrastructure across the European Union. It aims to establish stringent security requirements for both digital and physical critical infrastructure, ensuring that they are protected against cyber threats. The self-assessment tool for CRA helps users assess their compliance with the cybersecurity provisions outlined in the regulation. 
  • FDA (Food and Drug Administration):
    The FDA regulation, primarily focused on the healthcare and pharmaceutical industries, addresses the safety, effectiveness, and security of medical devices and other health-related technologies. The self-assessment questionnaire evaluates compliance with FDA’s cybersecurity guidelines for connected medical devices and healthcare systems. 
  • NIS2 (Network and Information Systems Directive):
    NIS2 is a European Union directive designed to enhance the overall level of cybersecurity across essential services, including energy, transport, banking, and digital infrastructure. It establishes requirements for the protection of network and information systems from cyber incidents. The self-assessment tool for NIS2 helps organizations assess how well they are implementing these cybersecurity measures. 

Purpose of the Compliance Questionnaires #

These compliance questionnaires are offered with the goal of providing users with an initial understanding of their compliance status relative to the relevant regulations. Completing the questionnaires is quick and easy, usually taking just a few minutes. The objective is to give users a snapshot of how well they align with the regulatory frameworks that apply to their sector. 

By filling out the questionnaires, users can get a clearer picture of their compliance status, allowing them to identify areas for improvement. If users wish to gain further insights into their compliance, they can request a detailed diagnosis from MyOrbik’s cybersecurity laboratory team. This saves time during initial meetings and enables us to provide more targeted advice based on the findings from the self-assessment report. 

Repeating the Questionnaires #

The questionnaires can be completed as many times as needed. This flexibility ensures that users can continuously track their progress and adjust their approach as they work towards full regulatory compliance. By retaking the questionnaire after making improvements, users can see how their compliance status evolves over time. 

Requesting a Cybersecurity Diagnosis #

Once the self-assessment questionnaire is completed, users have the option to request a more thorough diagnostic review from MyOrbik’s cybersecurity laboratory. This diagnostic process provides a deeper analysis of the compliance gaps and can offer actionable recommendations for improving the product’s security posture. 

To request this detailed diagnosis, simply click on the “Request Diagnostic” button or contact us via email at info@orbik-cybersecurity.com. Our team will then review the information gathered from the self-assessment and provide personalized guidance to help you meet the necessary regulatory standards. 

 

By using these tools, MyOrbik offers a streamlined approach to compliance management, helping users save time and make informed decisions about their cybersecurity and regulatory readiness. 

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