I think the most important steps about a project proposal is having realistic expectations of the project. Being specific and having clear expectations for the device and the processes going into maki...

A heart monitor is a device that adheres to a patient's chest for a specified amount of time and records their heartbeat in that duration. A functional requirement is that it must be able to accuratel...

There will always be some form of change control as long as these documents are not in a "draft" state. If the document has a revision associated with it, any and all changes will go through change co...

I have worked in a medical device company as a quality engineer and although I did not directly work with design controls on new products, I did get a chance to learn about the processes quite a bit. ...

Validation during design controls is meant to provide evidence that the device inputs address the customer needs. This is vaguely captured by the following four facets of validation: planning, review,...

Design controls are crucial to risk mitigation, especially in a medical device company. Design controls are a series of steps taken to ensure that the inputs of the device is matched by the output of ...

Industry in general is a subject not really talked about in university classes often. There is never a lot of insight being provided into medical device companies, how they operate, and what kind of r...

I also have experience in quality, specifically the risk management side of medical devices. However, rather than being a Clinical Quality Auditor, I think I would be more suited for being a Monitor. ...

Although I am not interested in pursuing a career that involves clinical studies specifically, I think it would be really interesting to do a retrospective study on the same treatment in different cou...

In this scenario, a small division of a big medical device company will start developing stents. The company primarily focuses on orthopedics and is starting to develop smaller divisions to branch out...

I'll talk about two positive changes to the internal and external environment (strengths and opportunities). An orthopedic implant company is selling a titanium hip stem in the United States. During a...

Something interesting that some medical device companies are doing is marketing directly to the patient. While most sales and marketing efforts are done towards clinicians, surgeons, and hospitals, sp...

There are a couple of key differences between nonprofit organizations and not-for-profit organizations; I am not sure which one the original poster is referring to, so I will write mainly on not-for-p...

In my opinion, basic business literacy would be a great class to take and essential if one plans on going into industry. I agree wholeheartedly that the engineering management course was very surface ...

There are a lot of factors to consider when thinking about the morality of the "Corporate Veil." The importance of the corporate veil is that it separates the business' assets from the assets of the o...