ISO 13485:2016
IT Service Management Systems (ITSM).
Streamline, Standardize, and Strengthen Your IT Services
ISO 13485:2016 is the internationally recognized standard for Quality Management Systems in the medical device industry. It provides a comprehensive framework that helps organizations design, produce, install and service medical devices that consistently meet regulatory and customer requirements. The standard outlines how to establish, implement, maintain and continually improve a quality system tailored specifically to the safety and reliability needs of medical devices.
By implementing ISO 13485:2016, organizations ensure their processes are controlled, their teams are well trained and their products meet the highest standards of quality and patient safety.
ISO 13485:2016 is widely used across the global medical device sector and is trusted by regulators, manufacturers and healthcare providers. It strengthens an organizations ability to deliver safe and effective medical devices, comply with regulatory requirements and manage risks throughout the product lifecycle. Although certification is not mandatory, it is often required by many markets and industry partners as evidence of strong quality management.
Key business benefits include the following
• Increased product safety. The standard supports robust process control, risk management and traceability, ensuring safer medical devices.
• Regulatory compliance. ISO 13485:2016 aligns with global medical device regulations and helps organizations meet essential legal requirements.
• Higher customer and patient confidence. Consistent quality and reliability build trust among healthcare providers and end users.
• Improved process efficiency. The standard promotes structured documentation, controlled workflows and better decision making, leading to reduced errors and improved outcomes.
• Continuous improvement. Ongoing monitoring, audits and reviews support continuous enhancement of the quality management system.
ISO 13485:2016 Services by Silverstrand Solutions
Silverstrand Solutions provides expert guidance for organizations involved in medical device design, manufacturing and service delivery. Through professional gap assessments, documentation support and hands on implementation assistance, Silverstrand Solutions helps businesses establish robust quality management systems and move confidently toward ISO 13485:2016 certification.