I agree with the previous poster in that project team work culture may differ greatly with the general company work culture. I interned briefly at Stryker and my team was quite supportive and cooperat...

Each process taken taken in the biomedical industry roughly follows the PDCA cycle, either on a larger project-based scale, or smaller continuous improvements within departments. The planning phase in...

Each individual member of a project team reporting progress on their own tasks is an incredibly useful tool for a project manager because they are able to quantify exactly how the project is progressi...

A role that has been around for a long time but is sometimes severely underutilized in the biomedical industry is usability engineering. Usability engineering is a term for people who help alter desig...

Are there any topics in Project Management that one would find in a Medical Device company that are unique to the biomedical industry? Conversely, are there any topics that appear frequently in Proj...

Increasing one's emotional intelligence (EI) is a lot harder and more personalized than increasing one's technical knowledge or critical thinking skills. I think something really important in raising ...

An example of contract law can be a joint replacement (JR) company buying their raw materials from a company specializing in metal. The offer and acceptance of the contract would be the terms of the a...

As the other posts have already mentioned, confidentiality agreements contain all of the basic components of a contract. Offer and acceptance indicates that both parties are aware of the agreement and...

I have not experienced gift-giving in the corporate world myself, although we did have training on it. As a commentor above has said, it is pretty similar to academia where an instructor accepting a g...

I think something that is heavily under-utilized in corporate settings is "esteem" in Maslow's hierarchy of needs. Starting from the bottom, I believe that physiological and safety needs are likely be...

Organizational structures will affect project management in the way the project is conducted and how much power the project manager, functional lead, or executive head will have. A functional organiza...

In my personal experience I have only experienced a "Weak Matrix" organization, so I can only speak to that scenario from experience, but I can assume how it might work in a "Strong Matrix" organizati...

ISO 13485 is functionally the same as ISO 14971, however there is an additional requirement on following EU MDR (European Union Medical Device Regulations). EU MDR does have some significant differenc...

I have interned with a risk management team of a medical device whiles they were dealing with a pretty big non-conformance in their processes, so I have had experience in the CAPA process. CAPA stands...

Risk management happens throughout the lifecycle of the device, so it is absolutely looked at to determine the rewards and profits that the device could bring. However, it is often not the primary rea...