To coordinate between risk and verification validation results, a dynamic risk assessment system can be used to consider the results. Verification and...

FDA and ISO should begin to change their requirements. All of their requirements were written where the submissions were done in concrete steps. Many ...

Engineers should "fight" for an ideal design in a way which describes their design as a benefit to the business. In design, usually user needs will co...

There is a conflict when it comes to honest/proper communication and using the nocebo or placebo effect as a therapeutic tool. Patients entering a cli...

Clinical trials are indeed very long and very expensive because of the ethics, regulatory demands, and demands for solid results which go into each cl...

As mentioned, a blinded study is a bit difficult to have honest conversations with the patient as it could compromise the study integrity. If a patien...

Effective promotion and ethical communication relies heavily on how well the science is communicated. As was mentioned, marketing campaigns should be ...

One factor that hasn't been really mentioned which is important for medical device marketing is being able to capture the trust of the consumer, wheth...

To answer the question of what should the threshold of misunderstanding be, if you define a misunderstanding to be critical based on a risk that it po...

For long-term goals in order to remain an established company, going public is almost a requirement in my mind. A private company when it goes public ...

Negative cash flow is definitely more influential than profit itself when evaluating when companies fail. Getting to a negative cash flow indicates nu...

One critical factor which could be overlooked with "extremely" innovative technologies would be the payback period. Payback period is the length of ti...

Some of the communication troubles between QA and QC because integration of the two is tricky due to the nature of how they deal with quality. QA focu...

Adding on with a specific example of incomplete documentation missing which leads to a failed audit is the lack of "assumed" process in the documentat...

Specifically when comparing QA/QC in the development stages of medical devices versus in the post-market surveillance, companies should adapt their st...