BS ISO 21485:2013

Comprehensive Quality Management for Medical Devices

BS ISO 21485:2013 is the essential British Standard for medical device manufacturers, providing a robust framework for quality management systems (QMS). Developed in collaboration with industry experts, this standard outlines the requirements for demonstrating the ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.

Ensure Regulatory Compliance

Compliance with BS ISO 21485:2013 is a critical requirement for medical device manufacturers seeking to access global markets. This standard aligns with the latest regulations, helping organizations:

• Demonstrate conformity to regulatory requirements
• Improve the safety and effectiveness of medical devices
• Enhance customer confidence in product quality
• Streamline the product approval process

Optimize Quality Management Processes

At the core of BS ISO 21485:2013 is a focus on establishing and maintaining a robust QMS. Organizations can leverage this standard to:

• Clearly define roles, responsibilities, and authorities within the organization
• Implement effective documentation and record-keeping procedures
• Establish robust design and development processes
• Implement comprehensive purchasing and supplier management controls
• Ensure effective production and service provision
• Maintain effective monitoring, measurement, analysis, and improvement processes

Deliver Safe and Effective Medical Devices

By adhering to the requirements of BS ISO 21485:2013, medical device manufacturers can demonstrate their commitment to quality, safety, and customer satisfaction. Key benefits include:

• Improved product quality and reliability
• Reduced risk of non-conformities and product recalls
• Enhanced customer trust and loyalty
• Increased operational efficiency and cost-effectiveness
• Competitive advantage in global medical device markets

Invest in Quality Excellence

BS ISO 21485:2013 is an essential standard for any organization involved in the design, development, production, installation, and servicing of medical devices. By implementing this standard, medical device manufacturers can streamline their operations, improve product quality, and demonstrate their commitment to regulatory compliance and customer satisfaction.