What is the ISO 13485 policy ?

The ISO 13485 policy is an essential framework for medical device manufacturers to establish quality management systems that comply with relevant legal and regulatory requirements. It covers a wide range of aspects, including design and development, production, storage, distribution, installation, servicing, and post-market surveillance. The policy encompasses every phase of a medical device's lifecycle, from conception to discontinuation.

Complying with the ISO 13485 policy has several significant benefits for medical device manufacturers. Firstly, it ensures that companies meet regulatory requirements and reduce the risk of product recalls or non-compliance penalties. Secondly, the ISO 13485 policy enhances the overall quality of medical devices. By establishing rigorous quality management systems, manufacturers can identify and address potential issues early in the process, resulting in safer and more reliable products.

ISO 13485 policy is an international standard that outlines the requirements for a comprehensive quality management system in the medical device industry.

The ISO 13485 policy covers a wide range of aspects, including design and development, production, storage, distribution, installation, servicing, and post-market surveillance. It encompasses every phase of a medical device's lifecycle, from conception to discontinuation.

The policy is developed by the International Organization for Standardization (ISO) and provides a framework for medical device manufacturers to establish quality management systems that comply with relevant legal and regulatory requirements.

By following the ISO 13485 policy, medical device manufacturers can ensure that their products meet the necessary regulatory and customer requirements, while maintaining their safety and effectiveness. This can help to reduce the risk of product recalls or non-compliance penalties and enhance the overall quality of medical devices.

In conclusion, the ISO 13485 policy is an essential tool for medical device manufacturers to establish quality management systems that comply with relevant legal and regulatory requirements. By following this policy, manufacturers can ensure that their products are safe and effective while maintaining their quality and reliability.