Community Forum

Ask a Question
Back to all

What is ISO 13485 Certification?

The safety of professionals and patients in clinics, hospitals, and other medical facilities is ensured by companies that receive ISO 13485 certification. ISO 13485 certification focuses on the criteria for enterprises that design and produce medical devices and equipment to establish and maintain a quality management system. It is required by the United States Food and Drug Administration for medical device manufacturers who require ISO 13485 Certification before delivering products to the United States.https://ias-certification.com/ca/iso-13485-certification-in-canada/