I've seen PFMEA used by process engineers for machines. PFMEA us used to identify the different failure modes for the machine and ways to fix this iss...

The validation process ensures that all the customer needs are met so that a successful, good quality, and reliable product is made. Thus, it requires...

Initiating document releases and revisions are a crucial part of an effective quality management of any device. In fact, there is a cycle that every d...

Design Matrix with columns for inputs, specifications, validation, and verification is a good starting point but each device has to adapt to its own d...

This is usually written out within the companies mission/vision statement. They really care about the quality of their products, especially in the med...

Some of the design verification plans that is done for companies that manufacture medical devices are to see if that devices meet their design specifi...

That is true. We did follow the design control process for capstone where we first wrote up the customer requirements, design requirements, test plans...

Compensating participants is a necessary part of any trial but there are ethical concerns that arise under coercion and exploitation. In third-world c...

Another main concern that nobody has brought up yet is informed consent. The individuals in the trial should make their own decision about whether the...

Placebo pills work because the person taking its expects that pill to work and it works(sometimes) because of the power of the mind. For instance, str...

To be in any position that requires marketing as an engineer, you have to be able to help service both the customer and the business. I feel like this...

If you really want to go into management type position(such as project manager or technical specialists), I would definity do an MBA since you have to...

Something that I have learned working as an intern is an MSA, or more specifically a Gage R&R study, in which a measurement system, in which our c...