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shavondraleak
@shavondraleak
Eminent Member
Joined: Feb 28, 2022
Last seen: Apr 19, 2022
Topics: 0 / Replies: 24
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RE: Discussion Topic: The de Novo 510(k) Process

The streamlining of processes is cost-effective in most cases as far as consistency and conformity across the board. “On October 5, 2021, FDA issued ...

2 years ago
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RE: Discussion Topic: Make a few, sell a few

Paradoxical as this idea and question seem to be if you take a moment to think about medical devices already on the market it is obvious medical docto...

2 years ago
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RE: Discussion Topic: The cost of Quality

Cost of Quality is the upfront cost for a guarantee in good faith practice for a product. The integrity of your brand is the reputation you have with ...

2 years ago
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RE: Discussion Topic: Biomaterial Selection

@alexia-coffer you stated, The three aspects of sustainability identified as “Triple Bottom Line,” or alternatively “Triple P: people, planet, and pr...

2 years ago
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RE: Discussion Topic: Biomaterial Selection

From the perspective of the project manager facilitating the selection of a biomaterial is a crucial component to the overall success or failure of th...

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

@alexbryant-harden You highlighted a very important component in the medical devices industry is the competition. "Some other key differences are that...

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

@takward You make a valid point about the budget and challenges of FDA approval. Do you think things will change at any point with the process of FDA ...

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

Project management is a paradigm across all projects whether it incorporates every step at each level or not, the flow is similar overall. There is a...

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

The medical device development field has numerous opportunities from the academic arena as well as the industry (Commercial) arena and one of them is ...

2 years ago
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