The ISO 13485 standard is an international standard that establishes requirements for quality management systems applied to medical devices and is used worldwide as a framework to ensure the quality and safety of medical devices.
The primary objective of the ISO 13485 standard is to establish an effective and consistent quality management system for the manufacturing, distribution, and post-market servicing of medical devices. Its focus is on ensuring that medical devices are safe and comply with regulatory requirements.
It applies to all organizations involved at any stage of the lifecycle of a medical device, from design and development to production, distribution, installation, and post-market servicing. This includes medical device manufacturers, component suppliers, distributors, and related service organizations.
Therefore, it is a fundamental standard for ensuring the quality and safety of medical devices and facilitating compliance with regulatory requirements in this critical industry.
Organizations involved in the manufacturing and distribution of medical devices often seek ISO 13485 certification to demonstrate their commitment to the quality and safety of their products.
If you need to implement a quality management system under the ISO 13485 standard, we can assist you at SQS. Please feel free to ">contact us for more information!