I believe something like this would definitely violate your NDA or CDA. IMO your manager made a great decision. Just having the wrong logo is enough for a violation depending on what is patented. Comp...

We learned about Anti-kick back laws that help to avoid companies buying referrals through rewards and services. Are there any recent examples that you can name of medical device companies that suffer...

I really enjoyed this course. As a student of BME, I find classes in this field do not translate itself to industry all that well. Classes seem more geared toward the functionality of medical devices....

For collaboration projects, I would consider a Product Organizational Structure. This structure has managers reporting to the head of the company by product type. Each division within the organization...

Firstly, individuals need to be selected that are the best fit for roles within the scope of the project. Individuals who possess the knowledge and have unique backgrounds (diversity!) will be heavily...

I work in a matrix organization as a Manufacturing Engineer. I love this organizational style because information travels relatively quickly. Just last week I needed help from Regulatory concerning a ...

Regulation and standards should be abided by regardless of cost. Calibrations/maintenance are costly, but must be done. Safety inspections - also costly but must be done. Subscribing to these database...

AFAP is deemed acceptable when death or serious deterioration of health is unlikely. ALARP is not acceptable with regard to economic consideration. ALARP has more to do with acceptability of the risk....

From personal experience, I know that the most difficulty in risk management is the need to state a reason for the result. Filling out the risk management assessment gives results. These results, howe...

Legacy devices can be existing devices, modified hardware, and modified software. Legacy medical devices should conform to IEC 62366, a standard that specifies usability requirements for the developme...

It's very difficult to select one part of the DPP over the others. If I were to select one I would have to say scope management plan. This determines how the project scope should be defined, developed...

In design control, there are "checks" to verify that everything (mostly) is accounted for. Companies must question whether the design outputs conform to the design inputs. Was the design done right? W...