What is ISO 13485:2018 ?

ISO 13485:2018 is an essential international standard that outlines the requirements for medical device manufacturers. It is designed to ensure the safety, quality, and regulatory compliance of medical devices. The standard provides a framework for companies to ensure that their processes, products, and services meet both regulatory and customer requirements.

ISO 13485:2018 certification is crucial for medical device manufacturers as it helps them demonstrate their commitment to producing safe and effective products. The standard establishes a systematic approach towards risk management and quality control, ensuring that companies adhere to good manufacturing practices and consistently meet customer expectations.

ISO 13485:2018 key requirements include:

Management System: The organization must have a management system that meets the requirements of ISO 9001.

Design and Development: The organization must ensure that medical devices are designed and developed in accordance with the requirements of ISO 13485:2018 and other relevant regulations.

Documentation: The organization must maintain records that demonstrate compliance with ISO 13485:2018 and other relevant regulations.

Testing: The organization must perform testing to verify that medical devices meet the requirements of ISO 13485:2018 and other relevant regulations.

Quality Control: The organization must implement a quality control system to ensure that medical devices are consistently produced in accordance with the requirements of ISO 13485:2018 and other relevant regulations.

By adhering to ISO 13485:2018, medical device manufacturers can demonstrate their commitment to delivering safe and effective products to the market, while complying with legal and regulatory obligations. Compliance with ISO 13485:2018 is crucial for medical device manufacturers as it helps them demonstrate their commitment to producing safe and effective products. The standard establishes a systematic approach towards risk management and quality control, ensuring that companies adhere to good manufacturing practices and consistently meet customer expectations.