Posted by: @savery115 A small part of the lecture reviewed Upper Management vs Middle Management. Upper Management people are strategic and tend to set the groundwork and vision for what the company ...

Posted by: @rgp29 Hello everyone, As I was listening to this week's lecture, it called my attention the fact that companies can only give gifts of 100$ to the physicians and those gifts have to be re...

Posted by: @fo3 As learned this week, it is important to protect our ideas and inventions and to do so in the appropriate legal manner. Part of the lesson discussed Non-disclosure agreements, or cont...

I haven't had the opportunity to work with a risk management team, but I've noticed that brainstorming is the most used tool. Has anyone used the fish bone diagram? If so, how effective was it?

When dealing with risk, in what instances would it be okay to accept the risk in medical device development? Is it worth accepting?

Posted by: @orleron Think about a medical device being used during a surgery. The surgeon is scrubbed in and working on the patient. The techs in the OR are following the surgeon's instructions to ha...

Although all of these roles are critical to a successful DDP, the one that stands out most to me is the quality management plan. It simply determines quality policies and procedures relevant to the pr...

I think that one of the major issues that may arise in design control is organization. You want the documentation to be well organized with minimal changes needed. Time is also a critical factor. I al...

Before a biomaterial goes into the human body, it must first be tested for biocompatibility. These various tests include cytotoxicity, genotoxicity, systemic toxicity, toxikokinetics, hemocompatibilit...

Choosing the best biomaterial can either make or break a research project. For instance, when developing a biomedical device to be implanted, it is important to choose a material that will not be reje...