The difference between ISO 13485 and 21 CFR 820 lies in their scope and approach to medical device quality management. ISO 13485 is an international standard focusing on risk-based quality management, emphasizing global compliance, risk management, and post-market surveillance. In contrast, 21 CFR 820 is a U.S.-specific FDA regulation focused on device safety and effectiveness…
ISO 13485 sets the standard for quality management systems in the medical device industry. It outlines specific documentation requirements that companies must follow to ensure their products meet regulatory standards. These ISO 13485 documentation requirements are an essential guide for medical device manufacturers to implement and maintain an effective quality management system and to ensure…
ISO 13485 and ISO 9001 are quality management system standards that help organizations improve their processes and meet customer needs. While they share some similarities, they serve different purposes and industries. When comparing ISO 13485 vs ISO 9001, ISO 13485 is specifically tailored for medical device companies with a focus on safety and regulatory compliance,…
ISO 13485 certification proves a company’s commitment to quality in medical device manufacturing. This standard sets rules for creating and keeping a quality management system. Companies seeking to meet ISO 13485 certification requirements must meet these specific requirements for safety, risk management, and regulatory compliance. Getting certified involves setting up processes that match the standard’s…
Utilizing an ISO 13485 implementation guide is a crucial resource for medical device companies looking to enhance their quality management systems. ISO 13485 provides a comprehensive framework to ensure that products consistently meet customer and regulatory requirements. By implementing this standard, companies can improve processes, reduce risks, and ensure the safety and effectiveness of their…
ISO 13485 certification is a big deal for medical device companies. It shows you meet quality standards and can make safe products. Getting certified takes work, but it’s worth it. An ISO 13485 certification checklist helps you get ready for the audit and make sure you’ve covered all the bases. The ISO 13485 certification checklist…
Risk management in ISO 13485 is a key part of making safe medical devices. ISO 13485 sets rules for quality control in the medical device industry. It tells companies how to find and deal with risks when making products. The 2016 update to ISO 13485 puts more focus on risk. Companies need to think about…
