BS ISO 16038:2017 - Essential Standard for Health Care Technology

The BS ISO 16038:2017 standard, with ISBN 978 0 580 95381 1, is a pivotal resource within the health care technology sector. Published in January 2018, this comprehensive document is designed to support the effective design, development, and implementation of medical devices that contribute to patient safety and quality of care.

This international standard provides detailed guidelines on the performance evaluation of health technology. It outlines specific methodologies to assess the adaptability, reliability, and overall efficiency of medical devices in real-world settings. Compliance with BS ISO 16038:2017 ensures that manufacturers and health technology stakeholders meet the essential criteria for safety and efficacy, aligning with global best practices.

By adhering to the directives set forth in this standard, organizations can enhance their operational framework, minimizing risks associated with medical technology deployment. The document emphasizes critical areas such as risk management, system integration, and post-market surveillance, making it an indispensable tool for quality assurance.

With a focus on patient-centric outcomes, BS ISO 16038:2017 highlights the importance of user-centered design, ensuring that devices are not only effective but also accessible and easy to use for healthcare professionals and patients alike. This approach promotes better patient compliance and satisfaction, resulting in improved health outcomes.

The standard is available in both hardcopy and PDF formats at a price of £308.00. Organizations committed to excellence in health care technology are encouraged to invest in this essential standard as part of their quality management system.

In conclusion, BS ISO 16038:2017 stands as a backbone for improving health care technology processes and outcomes. It supports the evolution of medical devices through rigorous assessment and ensures that health care systems operate at the highest standards of safety and effectiveness.