What is ISO 14155: 2018 ?

ISO 14155: 2018 is an international standard that is widely recognized in the field of medical devices. It is designed to ensure the protection of human subjects and the reliability of clinical data collected during clinical investigations involving medical devices.ISO 14155: 2018 provides guidelines for the design, conduct, recording, and reporting of clinical investigations involving medical devices. The primary objective of this standard is to ensure the ethical and scientific integrity of these investigations.

ISO 15511: 2018 is an international standard developed by the International Organization for Standardization (ISO) that provides guidelines for conducting security assessments of information systems. It focuses on identifying and managing risks associated with the confidentiality, integrity, and availability of information in an organization.

ISO 15511: 2018 is significant in ensuring the security of information systems in organizations. By following the guidelines outlined in this standard, companies can effectively identify and mitigate potential security risks. Implementing ISO 15511: 2018 helps organizations build trust with their stakeholders by demonstrating their commitment to information security.

Furthermore, ISO 15511: 2018 enables organizations to prioritize their security efforts based on a systematic and standardized approach. It provides a common language and framework for communication between different departments, making it easier to coordinate security measures and share information across the organization. Compliance with this standard also increases the likelihood of meeting regulatory requirements related to information security.

In conclusion, ISO 14155: 2018 and ISO 15511: 2018 are both important international standards that can help organizations ensure the quality and safety of their products and services. Adhering to these standards can increase the likelihood of meeting regulatory requirements and building trust with stakeholders.