April 22, 2024
Length: 4-minute read.
Quick summary: ISO 27001 is more than a standard; it’s a key enabler to achieving information security in today’s digital ecosystem. This is important in every industry, including healthcare. Find out why this certification is so powerful in enterprise-wide and medical device lifecycle-specific applications, from protecting patient data, through reducing information security risks, to ensuring trust.
ISO 27001: a significant step forward for Magnetica
Today, data security is essential for all organisations, particularly those specialising in technical and medical innovation. In an age where data is more accessible than ever, companies are responsible for keeping their client’s information safe for moral and legal reasons. Securing sensitive and personally identifiable information (PII) is paramount; companies must look carefully at their systems and approach to risk management. When data collection and storage are necessary in the context of medical and health records, these concerns are amplified with additional ethical considerations and implications.
For these reasons, Magnetica recently embarked on a rigorous pathway to achieve ISO 27001 certification for our Australian facility, with plans to roll out to our UK and US locations. This standard is a benchmark for information and data security and represents our firm commitment to customer and patient privacy across our organisation and products.
We are delighted to report that we successfully achieved ISO 27001 certification. This accreditation proves that our information security management system (ISMS) has met all the required conditions for establishing, implementing, maintaining, and continual improvement. Alongside our other certifications (such as ISO 13485 and EN ISO 13485 Quality Management for Medical Devices) ISO 27001 provides a stable and robust foundation for Magnetica’s management systems.
This is a significant milestone in our strategy to commercialise our prototype 3T MSK Extremity MRI System. It reinforces our dedication to providing the highest-quality security in our medical imaging technologies. Further, ISO 27001 certification helps ensure compliance with some critical elements required by various medical device regulators in the markets we seek to enter over time.
ISO 27001 is a globally recognised standard that outlines the best practices for an information security management system. It helps organisations manage the security of assets such as financial information, intellectual property, employee details, and information entrusted by third parties. For us, it also means safeguarding sensitive medical data and ensuring the reliability and safe handling of the information.
Why is ISO 27001 so important for medical device manufacturers?
In medical device manufacturing, including MRI systems and sub-systems, the integrity and security of medical data are instrumental to safety and diagnostic outcomes. Our clients entrust us with sensitive information that requires the highest level of confidentiality and security. Here’s why data security and certifications such as ISO 27001 are critical:
1. Proven Data Security: ISO 27001 certification ensures that our systems are robust to protect data against unauthorised access and potential security threats. It covers both digital and physical security, providing comprehensive protection.
2. Increased Reliability and Trust: ISO 27001 enhances our reputation as a trustworthy partner. Hospitals, clinics, and healthcare providers who use our MRI systems and subsystem components can trust that the integrity and confidentiality of their patient data are maintained, making their operations smoother and safer.
3. Compliance and Regulatory Requirements: The healthcare industry is heavily regulated by necessity. Achieving a globally recognised certification such as ISO 27001 helps us comply with numerous legal, statutory, regulatory, and contractual requirements. It also ensures we are well-positioned for any new regulations that might arise in the future.
4. Improved Risk Management: By identifying, assessing, and addressing information security risks, we can provide a safer and more reliable product. This proactive risk management also helps reduce the costs associated with information security breaches.
5. Global Acceptance: ISO 27001 is recognised worldwide. This certification opens doors to global markets and demonstrates our commitment to industry best practices, regardless of our clients’ location.
Magnetica’s Commitment to Continuous Improvement
We are proud to say that achieving ISO 27001 certification is one of many key milestones in our ongoing commitment to excellence. We will continue to evaluate and refine our ISMS to ensure that it meets the dynamic challenges and evolving threats in information security while striving for future accreditations.
We understand the critical role that MRI technologies play in the healthcare sector. This certification helps assure our clients that every system we manufacture meets the highest international imaging and information security standards.
ISO 27001: Team Contributions
The complex and often challenging requirements for ISO 27001 accreditation and its ongoing maintenance require a truly “all hands on deck” approach from many departments across the Magnetica team. Our team’s collaborative efforts ensured that we met all requirements within the given timeframes, and we look forward to continuing to serve our clients with the highest standards of security and excellence.
If you would like to learn more about the scope of our ISO 27001 accreditation, visit our certifications page to view and download our certificates.
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