BS EN ISO 11981:2017 - TC Overview

BS EN ISO 11981:2017 is a crucial standard in the domain of health care technology, outlining the specifications and requirements for the analysis of medical devices and related systems. This standard provides a structured methodology to assess the functionality, safety, and performance of health care technologies, ensuring compliance with established guidelines. The document plays a pivotal role in facilitating the development, testing, and maintenance of medical devices, thus enhancing patient safety and care quality.

Key Features

• Compliance Framework: The standard is meticulously crafted to adhere to international best practices, ensuring that any device evaluated meets stringent criteria for safety and efficacy.
• Comprehensive Protocol: It details a comprehensive analysis protocol designed for various medical devices, making it a go-to reference for developers and manufacturers in health care technology.
• Health Care Technology Focus: With a primary emphasis on health care technology, it covers a wide range of devices from diagnostic tools to therapeutic equipment, providing insights applicable across various medical fields.

Recommended Audience

This standard is essential for professionals involved in the design, manufacture, and evaluation of medical devices, including regulatory affairs specialists, quality assurance personnel, and health care technology assessors. Its insights benefit technology developers, manufacturers, and practitioners aiming to align their devices with current health care standards.

Purchase Information

Available in both PDF and hardcopy formats, BS EN ISO 11981:2017 can be purchased for £188.00. This investment guarantees access to an invaluable resource that enhances expertise in health care technology assessment.

Applications and Benefits

Implementing BS EN ISO 11981:2017 in your quality management systems offers numerous benefits, including:

• Improved product reliability and performance in the health care sector.
• Enhanced risk management through systematic evaluations.
• Increased patient trust and satisfaction by adhering to safety standards.
• Facilitated compliance with regulatory requirements in the medical field.

By adopting this standard, organizations can navigate the complexities of medical device evaluation and improve health outcomes significantly. BS EN ISO 11981:2017 is not merely a reference; it is a foundation for innovation and excellence in health care technology.