I agree with @ks629 that the Project Planning Phase is extremely important and crucial to the project's success. going off what @ks629 mentioned, its necessary during the planning phase to mitigate ri...

I agree with @srg36 that even if you use project management tools like Pert charts, Gantt charts, there will still inevitably encounter pitfalls, but you will be able to more effectively manage these...

I agree with @hm243 that although it would be time consuming to update the document every time a new revision is made, it would be necessary to update all the relevant documents. So as @hm243 mentions...

I haven't worked at company that directly deals with this, but I think you can call any document anything so the importance is the content of the documentation. I think the necessary documentation/tit...

When first reading this post, I thought yes SOPs should be used in the research phase as well as development phase. However, thinking more about it I think the research phase is when there is more cre...

Chapter 3 of PBOK goes into detail of the 42 management processes. Table 3-1 on page 42 is a great visual that shows the mapping of the 42 management processes into the 5 Project Management Process Gr...

If I were a PM running a Risk Management meeting, I would ask the attendees of the meeting to have them familiarize themselves with with the ISO 14971 standard as @aij5 mentioned, and for them (i) co...

At Sloan we outsource the development so when we set up a Project plan we include a scope that clearly defines the deliverables, goals, and deadlines. Since it can be very expensive to develop a medic...

I agree with @hm243 that SOPs should be very detailed and descriptive laying out the instructions on how to create a specific product. As Dr. Simon mentions in lecture it should be written at a HS lev...

As @julienneviuya described Design History File (DHF) is created during the Design Phase during the product development stage of the device and is written before the production. Whereas the Design His...

In thinking about PMS and detection of problems, I thought about the process of notifying FDA and I cam across a NYT article. In the article, the director of healthy policy for the National Center ...

I agree with @iala4 that important sections to include are 1. Background 2. Objective 3. Scope 4. Time frame 5. Project budget 6.Key stakeholder. I also agree with @f-dot that a realistic budget and t...

In contrast to industry stakeholders, I work at a non-profit Sloan Kettering and when a clinician or nurse comes up with an invention-a new car-T cell therapy, or robotic surgical instrument they disc...

I agree with @bnb6 that I wouldn't consider there to be risks with the V&V process itself, but rather the risks if there was a problem during the verification stage or even the verification was co...

I agree with @julienneniuya and @asimbana that Verification is to confirm that design outputs equals the inputs. That the design numbers/specs set out are accomplished whereas with validation is the c...