What is the difference between ISO 13485 and EN ISO 13485 ?

ISO 13485 and EN ISO 13485 are both international standards that have been developed to establish quality management systems for medical devices. These standards were developed by the International Organization for Standardization (ISO) and the European Committee for Medical Equipment (CEN) to provide a common framework for medical device manufacturers to ensure the safety and effectiveness of their products.

ISO 13485 is an international standard that was developed by ISO to provide a framework for establishing, implementing, and maintaining a quality management system for medical devices. This standard is widely recognized and used as the benchmark for medical device quality management systems.

EN ISO 13485 is a European standard that has been developed to provide a framework for establishing, implementing, and maintaining a quality management system for medical devices in accordance with ISO 1348This standard is used in Europe to meet the regulatory requirements for medical device quality management systems.

The applicability of ISO and EN ISO 13485

ISO 13485 and EN ISO 13485 are both applicable to medical device manufacturers that are looking to establish, implement, or maintain a quality management system. These standards are designed to ensure that medical device manufacturers are able to continuously improve the quality of their products, identify and address risks to patient safety, and maintain the integrity of their quality management systems.

ISO 13485 is more widely recognized and used as the benchmark for medical device quality management systems. It is typically required by regulatory agencies in certain jurisdictions, such as the U.S. Food and Drug Administration (FDA).

EN ISO 13485 is a European standard that is used in Europe to meet the regulatory requirements for medical device quality management systems. It is also typically required by regulatory agencies in certain jurisdictions, such as the European Medicines Agency (EMA).

Key differences between ISO 13485 and EN ISO 13485

While ISO 13485 and EN ISO 13485 share many similarities, there are some key differences between the two. One of the main differences is the scope of the standard. ISO 13485 is an international standard that is designed to provide a global framework for medical device quality management systems. It is applicable to medical device manufacturers of all sizes and in all countries.

On the other hand, EN ISO 13485 is a European standard that is designed specifically for medical device manufacturers in Europe. It is intended to meet the regulatory requirements for medical device quality management systems in European countries and is only applicable to medical device manufacturers that are based in Europe.

Another key difference between the two standards is the certification requirements. ISO 13485 requires medical device manufacturers to demonstrate that they have implemented and maintain a quality management system that meets the requirements of the standard. This is done through a third-party certification body, which will conduct a review of the manufacturer's quality management system and issue a certificate that confirm that it meets the standard requirements.

EN ISO 13485 also requires medical device manufacturers to demonstrate that they have implemented and maintain a quality management system that meets the requirements of the standard. However, this is done through a notified body, which is a regulatory authority that has been authorized by the European Commission to review and approve the manufacturer's quality management system.

Conclusion

ISO 13485 and EN ISO 13485 are both international standards that are designed to establish quality management systems for medical devices. While they share many similarities, there are significant differences between the two in terms of scope, application, and certification requirements. Medical device manufacturers are required to choose the standard that best meets their needs and regulatory requirements.