The Discovery and Innovation phase as many have mentioned is the part of the life cycle that identifies customer needs, market, and competitors the “Climbing the Hill” phase where we search for ideas, unmet needs and look at how we…   Read more»

I think @smithshah sums it up well above. Design Verification Inputs=Outputs Design Validation Outputs=user needs and intended use Design Verification is- did you design the device correctly? Does your device meet the design requirements you set out in DID? Whereas…   Read more»

Hopefully if the user needs are not met as @hc255 mentions above, they would go back to the spec and make sure the output meets the user needs and intended use. I really don’t think there is any room for…   Read more»

So for this particular example to plan on selling a medical device in US and then decide in executing phase to sell in Japan, this would be a big scope creep in my opinion. I agree with the comments above,…   Read more»

If you’re in the Executing Phase it is the Project Manager’s responsibility to make sure that the team is performing their tasks on schedule and to deal with a team member’s vacation, or absence. As @cdj24 mentions, it should be…   Read more»

The PMBOK guide provides an overview of the Project Integration Management processes. I. Project charter as mentioned above II. Project Management Plan the process of performing the work defined in the project management plan to achieve the project’s objectives. III…   Read more»

I also think its important to identify what the new PM considers the error in the Scope to be. I agree with the above posts, but I think if the key Stakeholders had signed off on the scope of the…   Read more»

As a means to save time and money and still hit the product launch, I agree with @cdj24 to get as much research done as possible so that you don’t spend as much time and money on experiments that might…   Read more»

I agree with what most of said that determining the main cause of the equipment failure and to add to the discussion, I would say based on this week’s Simulation, the importance of logging these incidences. In case there is…   Read more»

As @merzkrashed mentions the FDA “results of a process cannot be FULLY verified by subsequent inspection and test” and ISO “processes for production and service provision where the resulting output cannot be verified by subsequent monitory or measurement”. So if…   Read more»

Since the previous devices’ IQ, OQ, and PQs have been explained in great detail, what would the IQ, OQ and PQ look like for other devices? For example a femoral implant? IQ- Femoral molding equipment meets the specs, working parts,…   Read more»

I agree with @asimbana that ISO provides more flexibility with their definition “processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measuring. Whereas the FDA has a stricter definition of “results of…   Read more»

I work at a non-profit hospital so for our more robust medical devices that we are unable to develop in-house, we use outside contractors to develop the devices. So the company will come and meet with surgeon that invented the…   Read more»

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 risk and to have contingency plan in place for as you mentioned, having integral…   Read more»

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 risk and to have contingency plan in place for…   Read more»

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 scenarios with these management tools. As Dr….   Read more»

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 that if the Work…   Read more»

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/titles would be what we encountered in this…   Read more»

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 creativity and you’re trying…   Read more»

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 Groups (Initiating, Planning, Executing,…   Read more»