Of the nine components, the three most interesting ones are: inputs, design history file, and planning. Inputs are essential to the overall success of a product. This phase pushes manufacturers to add...

Design input requirements typically can be sorted into 3 categories. These requirement categories are: functional, performance, and interface. Functional requirements specify what the device does, whi...

Clinical trials enable improved and/or emerging medicines and medical devices to be developed and later available to a wide consumer population. Patient participation makes clinical trials possible. W...

One consideration taken should be the benefit-risk ratio. Researchers should determine whether the benefits outweigh the risks by asking whether risks have been minimized and benefits maximized to the...

Clinical trials are an important step in evaluating product performance to determine its appropriateness as a commercially available product to the wider population. It’s essential to understand all o...

A medical device company based in Florida launches a novel commercial IUD with a biodegradable polymer coating. The company had hired subject matter experts on polymers to consult on the IUD developme...

Although the internet has definitely widened its customer reach through digital marketing, the digital divide should be considered. The digital divide essentially describes the gap between demographic...

“Push marketing” is in decline as customers have gained more control over what marketing they interact with. Therefore, modern marketing requires more direct interaction from marketing with customers....

As previous replies had stated, the corporate veil’s purpose is to separate the corporation and their shareholders; it essentially protects shareholders’ personal property. Initially, I would have bee...

At NJIT, currently BME and other engineering students are required to take one semester of an engineering management course. The class covers the fundamentals of engineering economics and project mana...

Like previous replies, I also believe it is unethical life-saving technology potentially may be disregarded if the profit margin is under 80%. A few replies had mentioned government intervention in th...

In a way, the audits performed by regulatory agencies are a way to measure the performance of the QA and QC departments. However, I would also argue the regulatory department within that same company ...

When a novel product (whether it is a medical device, drug, or biologic) seeks FDA approval, it can go to panel. A panel involves a certain group of experts under each FDA center that will meet to app...

While working as an intern for a commercial technical operations team, I was exposed to the change control process. The company I worked for had been aiming to expand the scope of their biologics deve...

I agree with points made above by previous users including the difference in review process. I particularly want to expand on the point regarding the difference in protocol for review of data. Each ag...