Medical Device Data Systems (MDDS)
Medical Device Data Systems (MDDS) are hardware or software products that transfer, store, convert formats, and display medical device data.
In 2011, the FDA published a final rule reclassifying Medical Device Data Systems (MDDS) as Class 1 medical devices exempt from 510(k) premarket notification requirements.
There are risks connected with MDDS which include the possibility of untimely data transfer, or the display of medical device data to name a few. In some cases, this can lead to inaccurate patient treatment or diagnosis.
As a result, this re-classification has increased the number of healthcare organizations looking to PTC to implement a compliant Quality Management System, such as PTC Integrity, to satisfy the FDA ruling.
PTC Integrity helps organizations achieve and streamline compliance, improve productivity and quality, and gain complete product visibility. Some of the medical device manufacturers who use the PTC Integrity solution include: Varian Medical Systems, Starkey Laboratories, and Kardium.