Given that the malfunction of a device can lead to a fatality, there is a crucial need to ensure that these devices are safe and are monitored effectively. Any complaints on devices need to be monitored so that if there is a need to recall the device, it can be done efficiently without any further impact to patients. One of the biggest challenges for many medical device manufacturers is the ability to collect data from different sources such as hospitals, doctors, and patients. In addition, the various regulations tied to the medical device safety industry elevate the need to audit compliance programs.
Marcelo Trevino weighs in on the various international regulations and audits in the medical device industry in January 2014 in Las Vegas at the 2nd Annual Medical Device Safety Monitoring and Reporting Conference. Trevino shares his thoughts on maintaining compliance.
How do you best prepare for internal and external compliance audits? How do you demonstrate your organization has a quality system in place to ensure safety and effectiveness of a medical device?
Click here read Trevino’s thoughts on compliance.