I think the most important steps about a project proposal is having realistic expectations of the project. Being specific and having clear expectation...

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 functiona...

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...

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...

Validation during design controls is meant to provide evidence that the device inputs address the customer needs. This is vaguely captured by the foll...

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...

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 devi...

I also have experience in quality, specifically the risk management side of medical devices. However, rather than being a Clinical Quality Auditor, I ...

Although I am not interested in pursuing a career that involves clinical studies specifically, I think it would be really interesting to do a retrospe...

In this scenario, a small division of a big medical device company will start developing stents. The company primarily focuses on orthopedics and is s...

I'll talk about two positive changes to the internal and external environment (strengths and opportunities). An orthopedic implant company is selling ...

Something interesting that some medical device companies are doing is marketing directly to the patient. While most sales and marketing efforts are do...

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...

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 t...

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 separ...