I think it’s always good to validate. I agree with @bb254 about engineers being trained per the SOP’s of the company and validating equipment. I think every employee, not just engineers should be made aware and trained in the validation…   Read more»

I disagree with @srg36 and agree with @alexandrabuga about the need to update revision number. I think it’s needed to have all the docs updated once a revision is made. I also agree that it’s a lot of work and…   Read more»

I agree with opinions stated above. I believe the major challenge facing medical device regulators as well as manufacturer comes down to differentiating between combination devices that are primarily devices and those that are medicinal. This will even get harders…   Read more»

I would add on to the list of various devices being classification differently between the US and EU with needle destruction devices. These are not considered medical devices in Europe but they are class III in the United States. In…   Read more»

My answer is maybe not. Other than the lecture video, I have limited area about this topic so I did a search on it and found some interesting information. From the lecture, various reasons you guys have mentioned and various…   Read more»

I agree with @alexandrabuga and @bb254 about the importance of Participation. I want to further emphasize the importance of participation, especially now in this era, participation is required to keep up with the market and maintain brand relevancy. Thanks to…   Read more»

I agree with you guys about the facts that there is no specific “good number” in the number of centers, multi-center clinical trials (MCCT) are expensive, there are a lot of aspects involving in MCCT. There is an article named…   Read more»

I am not working in the industry but my related field is vestibular rehabilitation. Currently, the focus of the field is toward automated systems and incorporating VR into physical rehabilitation. On the software side, the devices are made so that…   Read more»

I agreed with others about the differences between a patent and an NDA and how a patent gives you a legal proof of idea ownership. I would like to add to the idea of using NDA to protect ideas and…   Read more»

hi @merzkrashed, there are a few important points of information that if I were to sign an NDA form, I would definitely want to know in details: what information is considered confidential (definitions and boundaries), obligations/responsibilities or what might considered…   Read more»

Thank you for teaching this course. What I love most about it was the information-rich lessons and flexibility. The lessons were organized in separate topics and videos for each week so they are very easy to digest. I love the…   Read more»

Although I agree with @Adrian and many others about the matrix organization, I actually work in a small collaborating environment that use the project-based organization well. We were managed by a manager who reports to the boss. We report directly…   Read more»

I personally perfer upper management because I tend to look at things in a big picture and for long term processes and I agree with @dag56 and @scott that to be a upper manager, you should have to have certain…   Read more»

I was in a Matrix Organization where I had 2 direct bosses. The organization was not as clear as in the lecture that each project has a functional manager and a project manager. We typically work in various projects managed…   Read more»

I agree with other about the ISO 14971 and Yiming Chen about the key terms. I would like to elaborate on the major phases of the risk management process aligning with ISO 14971 standard (Adding on to @jtl27‘s comment). Major…   Read more»

I would like elaborate @merzkrashed‘s point about the FDA article “Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications”. When determining risk, the FDA assessing the severity, type, frequency, and length of harmful…   Read more»

I agree with Mark about the formality, necessity, and process of a risk and with @dag56 about profit/risk scale. I think it would also be beneficial to have prior smaller meeting building up to this big scale meeting that Mark…   Read more»

In my opinion, I don’t agree with the previous comment If I understand correctly about numerous trials. Instead, a company/manufacturer should have an established procedures with a defined operating conditions (units, lots, time etc) like @markabdelshahed has mentioned. First of…   Read more»

HI, @Scott, I haven’t done any protocols for medical devices but in the past working in clinical settings, we have planned different protocols, proposals. We mostly used Gpower analysis to determine the amount of subjects (samples) needed for a protocol…   Read more»

I agree with @gaberuiz13 that the tests have to make sense. Specifically, some products already have a set of “gold-standard” validation protocols to follow, such as blood pressure cuff. There are myriads of different kinds of blood pressure cuffs in…   Read more»