QTICS GROUP
Speciality: Testing, Inspection, and Certification Services
QTICS GROUP is a private business consulting and services company based in Budapest, Hungary, founded in 2021; with 4 employees and a 12.5% YoY workforce decline. The firm offers a broad range of services including cybersecurity, digital simulation, and IoT, and explicitly provides penetration testing and vulnerability testing services aligned with OWASP Top 10 and MITRE ATT&CK frameworks, emphasizing its expertise in security evaluation.
ISO 13485 and Cybersecurity/IT
Origin
ISO 13485 was developed by the International Organization for Standardization (ISO) and first published in 1996, with major revisions in 2003 and 2016. However, it's important to note that ISO 13485 is specifically a quality management system standard for medical devices and their related services—it is not primarily a cybersecurity or IT certification. The standard was created to help medical device manufacturers demonstrate their ability to provide devices and related services that consistently meet customer and regulatory requirements.
Industry Value
ISO 13485 is highly valued in the medical device industry because it provides a comprehensive framework for quality management that is recognized globally by regulatory authorities. Certification demonstrates an organization's commitment to product safety, regulatory compliance, and continuous improvement. While the standard itself focuses on quality management rather than cybersecurity specifically, the 2016 revision does address risk management throughout the product lifecycle, which can include cybersecurity considerations for software-based medical devices. For companies seeking to market medical devices internationally, ISO 13485 certification is often essential for regulatory approval and building customer confidence.
ISO 27001: Information Security Management Certification
Origin
ISO 27001 was developed by the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC), and was first published in 2005. It evolved from the British Standard BS 7799-2, which was created in the late 1990s. The standard was developed in response to the growing need for organizations to systematically manage and protect sensitive information in an increasingly digital business environment. ISO 27001 has since been revised, with major updates released in 2013 and 2022 to address evolving cybersecurity threats and best practices.
Industry Value and Importance
ISO 27001 is globally recognized as the leading standard for information security management systems (ISMS) and is valued for providing a systematic, risk-based approach to protecting sensitive data. Organizations that achieve ISO 27001 certification demonstrate to clients, partners, and regulators that they have implemented comprehensive security controls and are committed to maintaining confidentiality, integrity, and availability of information. The certification is particularly important for organizations handling sensitive data, as it helps meet regulatory compliance requirements, reduces security incidents, builds customer trust, and often provides a competitive advantage in procurement processes where information security assurance is required.