@ajm73 A PA physician pleaded guilty to accepting kickbacks from Insys in exchange for prescribing Subsys, a form of fentanyl. Insys labeled the payme...

This course left me with the idea that medical devices are not just devices; they are essentially entire departments made up of people of different ba...

While I have never been involved in meetings with outside consultants, I have had supervisors hire senior level physical therapists (PT) affiliated wi...

I think it is natural to believe that it takes a gradual rise from entry level to middle management to upper management. An entry level employee is gi...

It is important to to have a blend of positive personality and relevant experience among all project members. Managers generally have the option to ch...

At this point we are at the stage where our roles are set. We're researching our roles more closely and outlining the best way to present the most qua...

I agree with your assertion that there needs to be a line that sets the amount of risk associated with the device that can be managed. However, "as fa...

I believe at this point labels are a formality for companies to avoid litigation. The example of a coffee cup with a WARNING HOT label is always one t...

All drugs contain a level of risk to the user. Many of these chemicals are labeled safe by the FDA only in instances where a licensed physician may se...

@traceymraw I believe this article explains the expanding role academia now has on the medical device development process, as shown in this picture b...

Verification is a constant process for devices such as computer-assisted surgical systems (CASS). Initially CASSs were approved for use in minimally-i...

@as934 This is a good idea to consider for future studies, especially ones that incorporates physical activity. With the growing smart wearable market...

The main difference between verification and validation is the end user. Verification is more or less a premarket step that distinguishes between the ...

I was the secretary in my undergraduate BMES and among my roles was writing minutes for all our meetings. This was an important task as it gave us in ...