What is EN ISO 11886:2015 ?

EN ISO 11886:2015 is an essential standard for medical devices manufacturers, as it outlines the requirements for a quality management system specifically designed for these products. In this article, we will explain the purpose of EN ISO 11886:2015 and its key requirements.

Purpose of EN ISO 11886:2015

EN ISO 11886:2015 is designed to establish a globally accepted framework for quality management systems for medical devices. It is an international standard that helps organizations demonstrate their commitment to consistently meeting customer and regulatory requirements. By adhering to this standard, medical device manufacturers can ensure that their products are safe, effective, and meet the needs of their customers.

Key Requirements of EN ISO 11886:2015

EN ISO 11886:2015 provides several key requirements for medical device manufacturers. These requirements are designed to ensure that medical devices are safe, effective, and meet the needs of their customers. Some of the key requirements of EN ISO 11886:2015 include:

Medical device requirements: EN ISO 11886:2015 outlines the specific requirements for medical devices, including requirements for design, verification, and validation.

Documentation requirements: EN ISO 11886:2015 requires that medical device manufacturers maintain records that demonstrate their compliance with the standard. These records must include information about the design, verification, and validation of medical devices.

Quality management system requirements: EN ISO 11886:2015 outlines the requirements for a quality management system, including requirements for the development, implementation, and maintenance of the system.

Supplier requirements: EN ISO 11886:2015 requires medical device manufacturers to ensure that their suppliers meet the requirements of the standard.

Key Elements of EN ISO 11886:2016

EN ISO 11681:2016 is an international standard that provides guidelines and recommendations for technical writing. It is important for medical device manufacturers to understand the key elements of EN ISO 11681:2016 to ensure that their technical documents are easily understandable, coherent, and concise. Some of the key elements of EN ISO 11681:2016 include:

Document structure: EN ISO 11681:2016 provides guidelines for the structure of technical documents, including requirements for the use of headings, subheadings, and other elements to organize information.

Document content: EN ISO 11681:2016 outlines the content that should be included in technical documents, including requirements for including information about the design, verification, and validation of medical devices.

Document format: EN ISO 11681:2016 provides guidelines for the format of technical documents, including requirements for font, font size, and other elements to maintain consistency and clarity.

In conclusion, EN ISO 11886:2015 is an essential standard for medical device manufacturers, as it outlines the requirements for a quality management system specifically designed for these products. By adhering to this standard, medical device manufacturers can ensure that their products are safe, effective, and meet the needs of their customers.EN ISO 11681:2016 is an international standard that provides guidelines and recommendations for technical writing, ensuring clear and effective communication of complex information. By following these guidelines, technical writers can create documentation that is easily understandable, coherent, and concise, ensuring that end-users can comprehend the information effortlessly, leading to better product understanding and application.