With the rapid development and integration of software into medical devices, there is an increase in data breaches and cyber-attacks on public and private medical devices information systems. This ultimately leads to unwanted exposure of an organization’s confidential information and patient’s data and creates chaos in information security and legal systems. Therefore, medical device organizations must have highly skilled and trained cybersecurity teams, sophisticated information systems and must follow standard regulations to ensure compliance.

ISO 27001 certification comes in as a strong information security standard to build a security-oriented work environment. As an international standard, ISO 27001 provides guidance on implementing Information Security Management System (ISMS) across all industries and ensures that the information is protected against internal and external security threats. Why should a medical device organization be ISO 27001 certified? Here we explain.

1.Mitigates the Cybersecurity Risks: ISO 27001 certification reduces the chances of cybersecurity threats. The core requirements of the standard are addressed in Clauses 4.1 to 10.2.

Clause 4.1 – 4.4: This clause is about understanding the organization and its context, the needs and expectations of the interested parties and determining the scope of the ISMS.

Clause 5.1 – 5.3: This clause focuses on leadership and commitment, information security policy and the organizational roles, responsibilities and authorities.

Clause 6.1 – 6.3: It is about planning the actions to address the risks and opportunities and achieve the information security objectives.

Clause 7.1 – 7.5: This clause details the following:

  • Adequate level of resources into the establishment, implementation, maintenance and continual improvement of the ISMS.
  • Determine the competence of the people working on the ISMS that could affect its performance.
  • Confirmation that the people working on ISMS are aware of the information security policy, their contribution to the ISMS effectiveness and what happens when the ISMS does not conform to its requirements.
  • What to communicate about the ISMS, when to communicate, who will be the part of that communication and who will communicate?
  • Maintenance of all the ISMS related documents.

Clause 8.1 – 8.3: This set of clauses demonstrate the operational planning and control, the information security risk assessment and information security risk treatment.

Clause 9.1 – 9.3: It requires the organization to monitor, measure, analyze and evaluate the ISMS performance and effectiveness, conduct internal audits at planned intervals and perform the mandatory management review for ISO 27001.

Clause 10.1 – 10.2: This clause addresses the non-conformity and corrective actions and the continual evaluation and improvement of the ISMS.

2.Compliance Simplification: As certain ISO 27001 requirements overlap with other Regulatory guidelines, having an ISO certification will help you comply with the following regulations like the National Institute of Standards and Technology (NIST) cybersecurity framework and General Data Protection Regulation (GDPR). Though ISO 27001 certification does not cover every aspect of GDPR, it offers a solid framework for organizations looking to be GDPR compliant and covers the guidelines on data security, data integrity, risk assessment, record keeping and storage and general data protection.

3.Reduces the need for Customer Audits: Customers usually request an audit of systems before signing a deal. Having an ISO 27001 certification will provide credibility and trust and let your customers know that your information security best practices are up to date. This certification will automatically reduce the need for frequent customer audits and make your organization more prominent to customers from a security point of view. After certification organizations can feature the certificate on prominent places like, website homepage, footer and other high traffic web pages related to your organization.

Having discussed the above, with the ISO 27001 certification, the medical device organizations can ensure cybersecurity compliance. Holding this certificate will reduce the risks of cybersecurity threats, keeps the information confidential and demonstrate that the information security risks are under control. Is your organization ISO 27001 certified? Consult a proven Regulatory expert. Stay informed. Stay compliant.



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