12/9/2023 0 Comments Iso 13485 training onlineThey range from simple products like wound dressings to dentist chairs, cardiac pacers, life-support machines and diagnostic reagents. A medical device is any product intended for use in the diagnosis, prevention and treatment of medical conditions. With the standard applicable to so many types of products, the revision was no easy task. It has recently been revised to respond to the latest developments in quality management, technology and regulatory requirements that relate to the industry. ISO 13485:2016 sets out the requirements for a quality management system specific to the medical devices industry. ISO 13485:2016 Medical Devices, FDA, EU MDR, & MDSAP Why was ISO 13485 revised?
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |