What is EN ISO 13485:2012 ?

EN ISO 13485:2012 + AC 2012 and EN ISO 13299:2012 are both important international standards that are relevant to the medical device industry. EN ISO 13485:2012 + AC 2012 is an international standard that specifies requirements for a quality management system specifically for medical devices. On the other hand, EN ISO 13299:2012 is a technical standard that provides guidelines for writing and presenting thorough technical articles.

EN ISO 13485:2012 + AC 2012 is a framework that establishes criteria for demonstrating the ability to provide medical devices and related services that consistently meet customer and regulatory requirements. It is based on the ISO 9001:2008 process approach model for quality management systems and includes additional requirements specific to medical devices, such as risk management, traceability, and validation of processes.

EN ISO 13299:2012 is a technical standard that provides guidelines for writing and presenting thorough technical articles. The main purpose of this standard is to establish a common framework for technical article writing, ensuring consistency, accuracy, and clarity in technical communication.

Both EN ISO 13485:2012 + AC 2012 and EN ISO 13299:2012 are important for the medical device industry, as they help ensure that medical devices are safe, effective, and meet customer and regulatory requirements. By adhering to these standards, organizations involved in the design, development, production, installation, and servicing of medical devices can demonstrate their ability to provide high-quality medical devices and related services.