BS ISO 18835:2015

Comprehensive Healthcare Technology Standard

Introducing BS ISO 18835:2015, the essential standard for healthcare technology professionals. This comprehensive document outlines the requirements and guidelines for the design, development, and implementation of medical devices and systems. Whether you're a manufacturer, healthcare provider, or regulatory body, this standard is a must-have resource to ensure compliance and best practices in the rapidly evolving world of healthcare technology.

Key Features and Benefits

Ensure Patient Safety and Outcomes

• Detailed requirements for risk management and quality assurance to minimize potential hazards and optimize patient safety.
• Guidance on human factors engineering to enhance the usability and accessibility of medical devices.
• Provisions for post-market surveillance and continuous improvement to address emerging issues and evolving user needs.

Maintain Regulatory Compliance

• Alignment with the latest international regulations and standards, including ISO 13485 and IEC 62304.
• Clear directives on documentation, traceability, and change management to facilitate regulatory approval and audits.
• Support for compliance with regional and national healthcare regulations, ensuring your products and services are accepted worldwide.

Improve Interoperability and Integration

• Specifications for data exchange, communication protocols, and system integration to enable seamless integration with existing healthcare infrastructure.
• Guidance on cybersecurity and data privacy to protect sensitive patient information and maintain the integrity of medical systems.
• Provisions for remote monitoring, telemedicine, and other emerging healthcare technologies to future-proof your solutions.

Stay Ahead of the Curve

In the rapidly evolving healthcare technology landscape, staying up-to-date with the latest standards and best practices is crucial. By implementing the requirements outlined in BS ISO 18835:2015, you can demonstrate your commitment to patient safety, regulatory compliance, and technological innovation. Unlock new opportunities, enhance your competitive edge, and contribute to the advancement of healthcare technology with this essential standard.

Secure your copy of BS ISO 18835:2015 today and take the first step towards excellence in healthcare technology.