Patients demand that the technology being used to treat them is safe. Health care providers expect that the medical devices they use are up the task of saving lives and governments rely on their domestic manufacturers to deliver reliable, effective and competitive products to help keep their national industries moving forward. The business of saving lives is under an intense level of scrutiny from every angle.

To meet these demands, governments enact and constantly update legislation and regulations that aim to:

1. create comprehensive databases of medical devices and their component parts,
2. establish methods for tracing devices from production to disposal and
3. enable close marketplace oversight to monitor medical device safety and effectiveness

Whether its the European Commission or the US FDA, strict policies and complex procedures have multiplied in recent years and with every accident or failure in the system, new rules and regulations are enacted in a never ending cycle to reach the goal of consumer protection.  Everything from cotton swabs to PET scanners must meet or exceed the standards if it is to be economically viable.

A proven and reliable labeling and tracking system is the key to meeting these exacting standards.