Regulations keep evolving and healthcare organizations just have to learn to keep up with them while managing the risk factor for patients, hospitals as well as the device company, all at the same time.
Healthcare organizations are still using paper for patient records and data collection. This makes the data prone to human error. It is also difficult to store heaps of paper and also look for the right paperwork for audits.
As time goes by, the demand for improving patient outcomes is only going to increase, and it is already increasing at an accelerated rate. Patients and regulatory agencies are treating lack of machine maintenance and lack of visibility into why a medical device may have broken down very seriously.
The ever-increasing regulations and demand for improved patient outcomes necessitate a need to connect medical devices and keep an automated check on them for regulatory purposes. It is also in the best interest of patient health.