What is EN ISO 13485: 2021 ?

EN ISO 13485: 2012/A2: 2019 is an essential standard for the medical device industry that provides a framework for organizations to ensure the safety. efficacy. and reliability of their products. The standard is designed to establish and maintain an effective quality management system (QMS) that demonstrates compliance with applicable regulatory requirements.

The primary purpose of EN ISO 13485: 2012/A2: 2019 is to help organizations effectively control their operations. minimize risks. and deliver safe and reliable products consistently. The standard emphasizes both customer and regulatory requirements. requiring organizations to put processes in place to address these needs.

EN ISO 13485: 2012/A2: 2019 provides guidance on various aspects of sterile barrier system design. testing. and monitoring. It helps manufacturers implement robust processes and systems that comply with regulatory requirements. including the validation and control of sterile barrier systems used in pharmaceutical manufacturing processes.

EN ISO 13408-2: 2019 is a technical standard that focuses on the validation and control of sterile barrier systems used in the production of medicinal products. It is used to ensure the integrity and sterility of medicinal products. particularly those that are terminally sterilized. By adhering to the requirements outlined in EN ISO 13408-2. pharmaceutical companies can minimize the risk of contamination. maintain product quality. and ensure the safety of patients who rely on their products.

In conclusion. EN ISO 13485: 2012/A2: 2019 is an essential standard for the medical device industry that provides a framework for organizations to ensure the safety. efficacy. and reliability of their products. It emphasizes both customer and regulatory requirements and provides guidance on various aspects of sterile barrier system design. testing. and monitoring. Compliance with the standard is essential to minimize the risk of contamination. maintain product quality. and ensure the safety of patients who rely on their products.