ISO 21314:2019

ISO 21314:2019 - Healthcare Technology Standard

Ensure the safety and efficacy of your healthcare technology with the latest ISO 21314:2019 standard from the British Standards Institution (BSI). This comprehensive standard provides essential guidance for the design, development, and implementation of medical devices and related software, helping you navigate the complex regulatory landscape and deliver superior patient outcomes.

Key Features and Benefits:

• Comprehensive Guidance: ISO 21314:2019 covers a wide range of healthcare technology, including medical devices, in-vitro diagnostics, and health informatics applications. It provides detailed requirements and recommendations to ensure compliance with the latest industry regulations and best practices.
• Improved Patient Safety: By adhering to the standards outlined in ISO 21314:2019, you can minimize the risk of patient harm and improve the overall safety and reliability of your healthcare technology. This helps build trust with patients and healthcare providers.
• Regulatory Compliance: This standard is aligned with the essential requirements of the EU Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Device Regulation (IVDR), ensuring your products meet the necessary compliance standards for the European market.
• Enhanced Quality and Efficiency: ISO 21314:2019 provides guidance on quality management systems, risk management, and other key processes, helping you streamline your operations and deliver higher-quality healthcare technology to your customers.
• Competitive Advantage: By demonstrating your commitment to the latest industry standards, you can differentiate your products and services from the competition, positioning your organization as a leader in healthcare technology innovation.

Comprehensive Coverage for Healthcare Technology

ISO 21314:2019 is a must-have resource for any organization involved in the design, development, or implementation of healthcare technology. Whether you're working with medical devices, in-vitro diagnostics, or health informatics applications, this standard provides the guidance you need to ensure compliance, improve patient safety, and drive innovation in the healthcare industry.

Key Topics Covered:

• General requirements for the safety and performance of medical devices
• Risk management for medical devices
• Quality management systems for medical devices
• Design and development of medical devices
• Labeling and instructions for use
• Post-market surveillance and vigilance
• Requirements for in-vitro diagnostic medical devices
• Health informatics standards and interoperability

Unlock the full potential of your healthcare technology and ensure compliance with the latest industry standards by investing in ISO 21314:2019 from the British Standards Institution.