I would agree that success is mainly based on interpersonal skills and the rest based on technical skills. Many companies do train new employees on company policy, procedure, software, etc. and usuall...

In reference to health and wellness apps, I think period tracking apps for women would classify under the second category, because these apps can track whether or not a woman is pregnant, late on her ...

While everyone has said that initiating the project idea is the hardest part (and rightfully so because it determines if the project will exist at all or not), Verification is also something to consid...

I personally haven't worked under a project manager but from my experience working under another engineer, I can suggest that organization and patience is key with working with team members. The engin...

I do think that the world is moving towards a global medical device regulation system, especially with EU MDR. It is a hassle on companies though, changing their products so that they are compliant to...

In order to prevent from "low priority" projects from being stopped before finishing, the company should look at their budget, their current structure, and other parameters that would allow them to su...

I currently work as an intern at Getinge in the Production Engineering department. From the description of different types of organization structures, Getinge is more of a functional one, because ther...

With most models, they all have the consequence of not looking at the broad picture, since it only involves at the model at hand. The purpose of the project life cycle model is to view the process of ...

@sam-doksh I agree with your plan that medical devices planning should start with FDA Design Controls, and within those controls, budget, and other necessary constraints, companies can start planning ...

@jea42 Despite that EU MDR puts medical device companies in a difficult situation to quickly comply, I agree there are positives to the new regulations. With concepts like UDI that will allow better t...