What is EN 46012 ?

EN 46012 is a technical standard that establishes requirements for the development and manufacturing of medical devices. It is specifically focused on quality management systems and serves as a guideline for ensuring that medical devices meet the necessary safety and performance standards. The primary goal of EN 46012 is to establish a consistent framework for quality management in the medical device industry.

EN ISO 23247:2011 is applicable to various industries, including but not limited to automotive, aerospace, electronics, and machinery. It covers a wide range of documentation aspects, such as product structure, geometry, material specifications, tolerances, and assembly instructions.

The relevance of EN ISO 23247:2011 in technical writing lies in the fact that technical writers play a crucial role in implementing the guidelines outlined in this standard. Adopting EN ISO 23247:2011 principles allows technical writers to produce consistent, accurate, and easily understandable technical documentation. This not only benefits the end-users but also enhances the overall efficiency and effectiveness of the product development process.

In conclusion, EN 46012 and EN ISO 23247:2011 are both important standards that have a significant impact on the quality management of medical devices. Adhering to these standards can help ensure that medical devices are safe and effective for use by patients, and technical writers play a critical role in contributing to this goal.