BS EN ISO 15747:2019

Comprehensive Healthcare Technology Standard

Introducing BS EN ISO 15747:2019, the essential healthcare technology standard that ensures quality, safety, and compliance across the industry. This 26-page publication, available in PDF or hardcopy format, is the authoritative guide for healthcare professionals, manufacturers, and regulators alike.

Ensure Compliance and Quality

Adhering to the specifications outlined in BS EN ISO 15747:2019 is crucial for healthcare organizations and medical device manufacturers. This standard, which is identical to ISO 15747:2018, provides a comprehensive framework for:

• Designing and developing safe, reliable, and effective healthcare technology
• Implementing robust quality management systems
• Ensuring regulatory compliance and patient safety
• Streamlining the product development and approval process

Comprehensive Technical Specifications

BS EN ISO 15747:2019 covers a wide range of technical specifications and requirements, including:

• General requirements for healthcare technology design and development
• Quality management system principles and implementation
• Risk management and mitigation strategies
• Validation and verification procedures
• Labeling, packaging, and traceability requirements
• Post-market surveillance and vigilance protocols

Streamline Compliance and Improve Patient Outcomes

By adhering to the standards outlined in BS EN ISO 15747:2019, healthcare organizations and medical device manufacturers can:

• Demonstrate a commitment to quality and patient safety
• Streamline the product development and approval process
• Reduce the risk of non-compliance and associated penalties
• Improve patient outcomes and satisfaction through the use of safe, reliable, and effective healthcare technology

Invest in Quality and Compliance

Don't compromise on quality or compliance. Secure your copy of BS EN ISO 15747:2019 today and ensure your healthcare technology meets the highest standards of safety, reliability, and effectiveness. This comprehensive standard is an essential resource for healthcare professionals, manufacturers, and regulators alike.