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Forum Replies Created

RE: Discussion Topic: The de Novo 510(k) Process

The de Novo 510K process is classification procedure to classify the new medical devices which are not previously classified. The new rule has made the process easy by getting approval without the sub...

In forum Regulatory Basics for Medical Devices

8 years ago
RE: Approaches to Research

Research in academia is mostly ones passion to denote their time in innovations and research for the unknown outcome. It might also be personal in addressing a problem to find a solution. Research in ...

In forum Pre-clinical Device Development

8 years ago
RE: Discussion Topic: Brand new biomaterial

Depending on the usage/category of Biomaterials, like surface biomaterials, implants, they must undergo different types of testing which are set by ISO 10993 standards like cytotoxicity, genotoxicity,...

In forum Pre-clinical Device Development

8 years ago
RE: Research for the Fututre or Now?

I was very much interested in doing research in academia which would benefit people after a long time. But after working in academia research and seeing people getting benefited right away from indust...

In forum Pre-clinical Device Development

8 years ago
RE: Project Life Cycle

Planning and execution phase remains the most important phases. This is because in planning phase all the proper steps which are to be performed are laid out properly and in an orderly manner like all...

In forum Intro to Project Management

8 years ago
RE: Milestones Missed: Failure or Success?

Missing a milestone in the path of the project is considerd as a failure. However, that is not the end of the project or that doesnt mean that there is any compromise in the project in regard with its...

In forum Intro to Project Management

8 years ago
RE: Discussion Topic: Project Management in a medical device setting

Being a project manager for a medical device company is more challenging than a project manager for skyscraper building company. Medical devices should pass the FDA regulations which is more complicat...

In forum Intro to Project Management

8 years ago
RE: Professions in Academia and the Industry

Academia and Industry have their own advantages and disadvantages. I have been working in academia (research at NJIT) from 6 months and also have previous industry experience for an year. In research ...

In forum Introduction to Medical Device Development

8 years ago
RE: Discussion Topic: Practical vs. Informational courses

I believe academic and practical classes ratio should be 50:50. Knowing the basic required knowledge on a subject is as important as knowing where and how it is applied. Industry demands more practica...

In forum Introduction to Medical Device Development

8 years ago
RE: Discussion Topic: Academia vs. Industry

In academia, you can do the project having flexibility in the timing. Sometimes i used to go to lab at nights and finish my work. You can extend the deadlines depending on the time taken by the work t...

In forum Introduction to Medical Device Development

8 years ago
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