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 evaluation, risk controls, the evaluation of overall…   Read more»

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 accept the risk is…   Read more»

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 past? Which do you find the most beneficial or…   Read more»

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…   Read more»

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 based on the type of company it is? For me…   Read more»

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. Before this, when I was…   Read more»

Posted by: @hg93 Design Development Plan (DDP) contains:*final scope statement*scope management plan*quality management plan*communications management plan*team member list/responsibilities Communication management plan is the most important part of the DDP because communication management plan contains information on how to contact people…   Rea…[Read more]

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 safe before you bring the…   Read more»

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 DHF contents and how to…   Read more»

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. Limited Liability Companye. Running Corporationf. Corporation (S Corp. or C…   Read more»

Posted by: @orleron Being able to look at the financial statements of a company and determine some guesses on its health is a good skill to have. All public companies in the US must publish their financial statements quarterly and…   Read more»

There are so many things we can do to improve Quality Control. First of all, we can train employees.Ensuring quality throughout your process requires specific training for your employees. Not just the quality control officer will need education. This helps…   Read more»

Posted by: @merzkrashed Hi everyone, Let’s talk about how you can improve quality control department?Without quality control procedures, you could face product recalls or safety hazards that lead to expensive litigation.So, tell us about your ideas on how you can…   Read more»

In Both cases , there are advantages and disadvantages . first of all, let me say this. no one is creating a business and be sued later on. Any types of businesses require critical thinking. We lay down plans ,…   Read more»

Posted by: @orleron This is a phrase you will encounter sometimes. “The Cost of Quality” is a concept. Let’s say you have a product, and you do no QA/QC on it. For a while, you might do fine. The product…   Read more»

@jonyekwere Let me sum up my understanding between QA AND QC . First of all, QA is responsible for overall monitoring, coordination and reporting for quality whereas QC is responsible for inspection, measurement, testing as well as defect prevention activities on…   Read more»

@sanam I work at Saint Barnabas, and recently our team like many teams around the Saint Barnabas moved to remote work. So I’ve experienced first-hand how Implementing new software remote teams manage their projects, align on their tasks, and gain clarity on…   Read more»

@patricia But people  don’t always choose short-term rewards over long-run gain. All will depend of the research. It improves services and treatments not just for you but also for future generations. It helps develop new tests for diagnosis, treatments and…   Read more»

@bjv9 Today, because experiments on animals are cruel, expensive, and generally inapplicable to humans. The world’s most forward-thinking scientists have moved on to develop and use methods for studying diseases and testing products that replace animals and are actually relevant…   Read more»

@prateekch18 There is no hard and fast rule when it comes to the degree required for becoming a project manager. However, the expertise and skill level of a person plays an important role. Strengthening your project management skills and gaining…   Read more»