ISO 13485 CERTIFIED COMPANY SINCE JULY 6, 2022
What is ISO 13485?
ISO 13485 was developed to ensure that manufacturers are delivering the safest, highest quality products possible. This international standard requires organizations to demonstrate their quality management practices and sets out specific requirements needed for the medical device industry.
ISO 13485 requires accountability, compliance with regulations such as U.S. Food and Drug administration current good manufacturing practices, maintenance of documentation, and traceability of products. Medical devices are classified into 3 classes. API manufactures Class 1 products.
Devices placed into Class I offer the least potential for harm to the user and/or the patient. These devices generally have a simpler design than those devices that fall into the other two classes. Class I devices are not designed to assist or support life and, as such, are unlikely to pose any significant risk of illness or injury.