NDA would not substitute for the patent. NDA is helpful for your legal case when the person who signed the NDA uses company's idea as his own. However, NDA is not useful when the person who signed the...

I think that oral agreement are often looked upon warily because they are not easily enforceable. Contract that are written are can be easily presented for a legal defense than the oral testimony. It ...

I work at the company which manufactures dental prosthetics. I consider this organization as a functional based one since this organization structure is a hierarchical organization structure wherein p...

One of the method to use from the design perspective is R & M or reliability and maintainability. As a Design engineer, I want to make sure that the product will be reliable after further use. The...

There were a lot of mistakes can be made while implementing the FMEA. The mistakes cause the FMECA not meeting the objectives of it. Conceptually, Poka Yoke is able to fit into the Process FMEA. Failu...

I believe that design controls should be part of the process used to determine the commercial viability of a product in development. Design input requirements can help customers and stakeholders ident...

A mission statement communicates the organization’s reason for being, and how it aims to serve its key stakeholders. Customers, employees, and investors are the stakeholders most often emphasized, but...

The four branch model as the construct of emotional intelligence: (1) the ability to accurately perceive, appraise and express emotion; (2) the ability to use emotion to facilitate thinking; ...

I have not been a part of the audit during the the FDA or BSI visits. However, I have been called during the visit regarding the documents that I have written. Their main objective was to clear out th...

In 2016, the FDA issued a final deeming regulation that will regulate e-cigarettes as tobacco products, but the regulation, while addressing some key policy issues, still leaves significant regulatory...

There are many differences between doing research in academic and industry. I have had experienced both during my career. Amount of time given to the research in industry may not be as comparable to a...

The tests to assess the biocompability of the material should follow ISO 10993. The following tests should be done on the biomaterial for verification and validation of the product: Evaluation and tes...

While working on a project, we hit a roadblock during the verification phase. Before this obstacle, we have already spent most of our time and budget on the project. Before submitting 510k for our pro...

I think the challenges are different for other industries as opposed to medical device. These differences are in the regulations involved on a project of respective industries such as building a schoo...

I think initiation and planing phase is most important because in this phase you define your baseline. During these phases we gather the requirements and specifications for the project. Scope is defin...