Given the work that I do, I think the functional organization is the structure in which I would prefer to work. My organization is headed by a chief e...

From what I have observed during my time working in the medical device industry, non-competes do have an effect on those looking for jobs with rivals....

An NDA is not a substitute for a patent. Patents offer protections for IP, products, and services that far exceed the the protection from disclosure o...

ISO 14971:2007 is the major regulation governing risk management. The major risk management requirements for a medical device company include the impl...

I agree that AFAP represents a gray area, though that may perhaps be by design. Many of the standards are intentionally vague to allow flexibility to ...

On the company's end, things they can do for risk management outside of printed warnings include designing out the risk, implementing safeguards, and ...

My work in the regulated production setting refers back to my time spent as a clinical chemist in a high-complexity toxicology laboratory, not my curr...

I think that the biggest issue in design transfer surrounds the timing and coordination of the device design and manufacturing phases. Given the finan...

While I believe that all components of the DDP are important to medical device development, I would the scope statement to be among the most crucial t...

I think some major issues that arise from the insufficient use of design controls ultimately surround the increased likelihood of failures being reali...

I believe that placebo-controlled trials are both necessary, as well as ethical, given that the subject is not put at serious risk by not receiving tr...

I think the main benefit of double versus single-blind studies is to further reduce the introduction of both conscious and unconscious bias. Given tha...

I would argue that it is important for all personnel involved in clinical research to have at least some clinical background. While I would not expect...

Some circumstances where a court may deem piercing the corporate veil necessary include cases where the separation between the business and owner is n...

A vision statement communicates the purpose and values of a company by preparing a statement that broadly describes a goal the company wishes to accom...