Posted by: @bnb6 Dr. Simon said in his lecture, "Projects have a beginning and an end that are very well defined." During my experience at Stryker, I have seen projects put on hold due to lower prior...

Posted by: @rgp29 Hello everyone.Project managers need to be effective in a lot of ways. For example, you need to finish the project on time and the quality of the product need to be outstanding. How...

Posted by: @orleron One "fun" thing to talk about during the Regulatory lectures is the ongoing soap opera of what is happening to the 510(k) process. One of the key events in the saga was a controve...

Posted by: @vcf3 What tips can you give for a new Project Manager who has never been in that position before? I saw this article () with some useful tips, but I want to hear your real-life tips and e...

Posted by: @djr32 When you open your Google play store or Apple Store, you can find an app for everything, even things related for medical purposes, such as an app that measures blood pressure.Moreov...

Posted by: @quanzi A risk management file is the culmination of all documents related to the risk management process. It is a living document, and includes a risk management plan, risk analysis, risk...

Posted by: @lmathis When dealing with risk, in what instances would it be okay to accept the risk in medical device development? Is it worth accepting? When dealing with risk , the only time we can...

Posted by: @traceymraw Based on the risk management tools mentioned in the lecture (Failure Mode Effects Analysis (FMEA), Brainstorming, and Fish Bone Diagram), which have you used on projects in the...

I personally won't accept job based on company . I want to get my feet wet first . But they are few stuffs to consider. I want to be certain about my decision yo accept the job offer, take time to che...

Posted by: @sahitya-sadineni After watching the videos from this week's lecture, we have learned about the various company types. While thinking about this, would you consider turning down a position...

Posted by: @rgp29 Hello everyone, I have noticed how Dr. Simon keeps pointing out to importance of taking minutes in all the meeting of the team. I never really thought of how important they are. Bef...

Posted by: @hg93 Design Development Plan (DDP) contains:*final scope statement*scope management plan*quality management plan*communications management plan*team member list/responsibilities Communica...

Yes. it is important that you design and develop a medical device that is safe. FDA and EU and all other regulatory bodies throughout the world will want some assurances that your medical devices is s...

Posted by: @orleron We have begun learning about the Design History File (DHF) this module. We are more than halfway through the course, so congrats for making it this far! This module deals with the...

Posted by: @bb254 If you were to have ownership of a corporation, which type of corporation would you want to be an owner of?a. Sole Proprietorshipb. Partnershipc. Limited Liability Partnershipd. Lim...