ISO 13485 Certification: The Key to Compliance in Medical Device Manufacturing
If you are a manufacturer of medical devices, then you know how important it is to maintain compliance with regulatory requirements. Not only is it necessary to ensure that your devices are safe and effective, but it is also required by law. One way to achieve this compliance is through ISO 13485 certification, specifically designed for medical device manufacturers.
At ISO Internal Audits, we offer comprehensive ISO 13485 consulting and auditing services to help you achieve and maintain certification. Our team of experts has extensive knowledge and experience in the medical device industry, and we can help guide you through the certification process and ensure that your quality management system is fully compliant with all regulatory requirements.
ISO 13485 Certification: What Is It?
ISO 13485 is a quality management standard specifically designed for medical device manufacturers. It outlines the requirements for a comprehensive quality management system that covers all aspects of the device manufacturing process, from design and development to production and post-production activities. The standard also covers requirements for handling medical devices, including storage, distribution, and servicing.