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. Companies like Tiffany Co. actually patent…   Read more»

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. Yes, this is certainly important,…   Read more»

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 is dedicated to a particular product line. This certainly makes collaboration…   Read more»

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 sought out. From there, I would consider a…   Read more»

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 project. Many members in Regulatory were out due to the…   Read more»

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 databases are simply a necessity just like all the tasks above….   Read more»

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. Also ISO 14971 allows risks to be reduced…   Read more»

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, however, need to be further analyzed. After doing…   Read more»

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 development of medical devices. Having a summary of known use errors is a…   Read more»

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 and verified. I…   Read more»

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? Was the right device designed? That being said, it…   Read more»