From personal experience, signing NDAs can be nerve-wracking, especially for your first few jobs or projects. But it teaches you the importance of keeping a secret at the professional/industrial level...

NDAs have two purposes: to protect the company that issues them, and to guarantee that they can act against the consultant/staff member should they breach that agreement. NDAs are a must when a compan...

As we've discussed at length this week, we are no longer in the "old days" of consulting, when many backdoor bribes and rewards were given for simply cooperating with a provider. As a result, a confli...

From personal experience, there are a variety of ways to approach such a situation, especially when you need to work with other teams or departments; you almost need to speak different languages to di...

Mohammad, you provided great definitions for introducing both concepts. I’ll add to your points by explaining how these concepts really pan out in a real-world context. During my first job in the fie...

Design teams might confuse Design Controls and Project Management because they both involve overhead control. Where Design Controls focus on the design of the project and the processes within it, Proj...

FMEAs are indeed a useful tool for evaluating the types of failures a system could experience if one (or several) of its components fail. This is especially true for medical devices, which include var...

I believe risk acceptance and its effect(s) are directly tied to the quality of the risk assessment itself, which also affects the form of a response to the hazard. When risk assessment is conducted, ...

During my time as a co-op at GAF, I have witnessed a variety of hazards that had to be mitigated, mostly within the R&D labs. Each of the labs had a variety of equipment with varying levels of ris...

@shreya This is a great set of ideas to build upon for the complexities of developing & reviewing a potential product, especially regarding living documents, progress traceability & structure....

Both processes are necessary to ensure the product pleases two key stakeholders: the company itself and its customers. Maintaining this distinct difference between them enables specialized processes t...

Ideally, you’d imagine companies doing both. They need to fulfill regulatory requirements for the sake of remaining compliant, but they must strive to uphold product quality to maintain or improve the...

Design teams, from my experience, tend to prioritize the most realistic aspects of a design. The end goal is to meet the customer’s requirements, yes, but at the same time, they cannot expect us to pr...

Hi Jacob, you’ve provided a great definition of what makes an effective design input. There’s actually a mechanism that Dr. Simon discussed this week in the lecture. To turn a qualitative design goal ...

Meeting minutes are a useful tool for logging significant portions of a meeting, especially when discussing subjects such as design reviews/controls. This gives professionals the ability to keep tabs ...