Glossary
ISO 13485
What is ISO 13485?
ISO 13485 is an international standard that specifies requirements for a Quality Management System (QMS) specifically for organizations involved in the design, production, installation, and servicing of medical devices. The standard aims to ensure that medical devices consistently meet customer expectations and regulatory requirements throughout their lifecycle, from development to post-market activities. Compliance with ISO 13485 is often essential for regulatory approval in many countries, as it demonstrates a commitment to quality and safety in the medical device industry.
What are the benefits of ISO 13485?
The benefits of ISO 13485, the international standard for quality management systems in the medical device industry, include:
Efficient Risk Management: The standard emphasizes systematic risk management processes, helping organizations identify and mitigate potential risks throughout the product lifecycle.
Enhanced Operational Efficiency: ISO 13485 promotes continuous improvement and process optimization, resulting in reduced waste, faster cycle times, and improved overall efficiency.
Regulatory Compliance: Compliance with ISO 13485 facilitates adherence to various regulatory requirements, making it easier for organizations to access new markets and maintain their market position.
