ISO 13485 requirements help you streamline their regular processes. However, ISO 13485 goes beyond ISO 9001 with many controls specific to medical devices. ISO 13485 references the ISO 9001:2008 standard, not the latest 2015 version. revised Quality System Regulation (FDA 21 CFR 820) incorporates both standards. Many countries now base their regulatory requirements on ISO 905. ISO 13485 certification is a common first step for manufacturers seeking compliance with the Medical Device Directive (MDD) and the CE marking process in the European Union. Foundation for Compliance With FDA, MDD, or CE With compliant oversight, monitoring, and accountability, you can consistently meet critical requirements for medical device production. ISO 13485’s Quality Management System (QMS) practices establish protocols for quality control, ensuring safe and effective products. QMS Practices for Safe and Effective Medical Devices ISO 13485 gives you the tools for effective risk management, creating consistency across your organization to ensure safe and reliable products. The Benefits of ISO 13485 Certification Effective Risk Management To learn more about the basics of certification, download our free guide or contact us to speak with a consultant.

Certificates are issued by a third-party registrar following a certification audit, and everyone in your organization will need to be involved in the process. You must complete several steps to achieve and maintain certification.

With an ISO 13485 management system, you get more value from your operations, increasing productivity and cost-efficiency across your organization. ISO 13485 certification also streamlines your day-to-day manufacturing processes. They prove your commitment to quality and safety, building trust with consumers as you continually deliver safe, effective products and components. The medical device manufacturing requirements of ISO 13485 set your business apart.

With ISO-compliant quality management, you can reduce risk in the supply chain and increase customer satisfaction.īy meeting ISO 13485 requirements, you empower your business to move forward and engage new markets. The International Organization for Standardization (ISO) developed ISO 13485 to standardize the quality and safety requirements for medical devices worldwide. In the medical device industry, quality and safety are crucial.

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