While FDA has oversight over Medical devices for vetinary use they are not treated like devices for human use. Generally a quality system although recommended is not required and unless the device emits radiation registration and listing is not required. Below is an excerpt from the FDA website: How FDA Regulates Veterinary Devices The Federal...Read More
Recipient: Mediagnost GmbH. Product: Human Growth Hormone diagnostic kits Date: 5/8/12 Failure to establish and maintain adequate procedures to control all documents, as required by 21 CFR 820.40. For example: a. There are no procedures that address the control of electronic records. b. Access to two computer workstations that include in-process test data, finished device...Read More
CSV Training Course
Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email email@example.com for more info.