As many users of this post have said, biotechnology companies tend to look at the rewards more than the risks. I do think that there are some companies that actually do take into account the risks, bu...

There are some cases where the risk management team is the project team. From my experience from my undergraduate senior project, my project team was the risk management team because it was our projec...

As we have learned from this week’s lecture, hazards are a potential problem posed to you. It is just there and it does not do anything to you. These can include biohazard, chemical, electrical, or me...

As most users have said here, yes, I do feel safer knowing that medical devices include verification and validation testing. That goes to show that these companies and those building the device have t...

I do think that these 4 columns are enough information in a design matrix. Design inputs, design specifications, verification, and validation are the most important and basic information to include in...

I think that verification and validation can be conducted simultaneously, but that depends mostly on what design input it is for the device. Most of the time, verification testing is done first and va...

Design inputs, control, or requirements are targeted for the intended use of the device in terms of the user and patient needs. Design control helps to indicate the user needs and the specifications a...

The Design History File consists of many documentations, figures, protocols, appendices, and miscellaneous items. For any medical devices, simple or complex, they should be extremely detailed to note ...

Design teams should incorporate customer feedback into the design process very early on. They should not wait until the last minute to look or ask for feedback when time is ticking away and the deadli...

Artificial intelligence has been up on the rise as of recent years, but it seems to be slowly taking over this past year. I have not seen this much use of AI until this year. AI can be used to help st...

Clinical experiments require human testing and this is usually done after preclinical trials have passed in animals and are deemed safe to perform on human testing. It is more involved than animal tes...

Reading all of the responses, I would like to disagree that the placebo effect cannot have any negative effects on a clinical trial. I think that placebo effects can skew data results in pharmaceutica...

Generally, almost every company is going to be affected by external factors like the weather, politics, economy, competitors, and collaborators. There is really no escape as external factors are facto...

People who are designated in branding control the product’s image. I feel like I may be able to do a good enough job in that department. I do not have much confidence in my skills to say that I will b...

In terms of marketing, we all have seen those drug commercials on TV where it is usually a patient describing their story and how this medication saved their lives, while the doctor on screen agrees a...