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 a final rule on the De Novo Classification Process...

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 doctors are innovators and developers of important medi...

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 your loyal customers. As a former quality lab tech...

@alexia-coffer you stated, The three aspects of sustainability identified as “Triple Bottom Line,” or alternatively “Triple P: people, planet, and profit” show the balance or harmony between economic...

From the perspective of the project manager facilitating the selection of a biomaterial is a crucial component to the overall success or failure of the project. The first point of contact would be wit...

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

@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 approval in the area of medical devices as we have...

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 diagram that displays the flow of the project lif...

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