I think the optimal project management software should have intelligent automation and predictive analytics that all members of the team can use to see where the project is going, and also not have to...

I agree with how separating design controls and management can lead to issues with verification and validation. I think rushing these processes takes away the main point of verification, which is to m...

  I think design reviews and design changes are most important during the Check and Act phases of the PDCA cycle. The Check phase is important because it connects all the other phases of the desi...

One way to reduce “project myopia” is to connect the project lifecycle to the higher-ups at multiple points in the timeline. This ensures that the project is aligned with company goals and policies. I...

You bring up good points about the submersion and drying times of the bottle label, since the timing is important for adhesion and how strong the adhesion is. With more time, more bonds can be made, a...

The key theme across all these responses is that challenges in the regulatory section of project management must be addressed pre-emptively. Any issues must be predicted and prevented as opposed to re...

I think you make a good point about planning for uncertainty, since it is almost never possible for a best-case timeline for sure. This is especially applicable for Class II and III devices. One thing...

  I currently work in a neuroscience lab that deals with the Protecadherin gene in the brain. This gene codes for the “molecular barcode” of each neuron, and this barcode is used to ensure that n...

I myself have not worked in industry yet, but I asked some family members who do about your question. PERT and CPM are used more implicitly in practice than their textbook form that you have mentioned...

I like how it is very clear that continuous compliance is the main point regarding FDA “licensure.” From the standpoint of project management, this moves the focus from one approval milestone to conti...

I think everyone here did a good job at breaking down the conceptual difference between hazards and hazardous situations. Something new I have to add is how time and device evolution should not blur t...

I like how everyone emphasized how important structure, preparation, and inclusion is in risk management meetings. I want to talk more about the format of a meeting itself that can influence risk visi...

Everyone has brought up excellent points about Poka-Yoke and how it reduces errors on the production floor. However, something that no one has touched on yet is how Poka-Yoke can bridge the gap betwee...

I agree that design controls are more than a regulatory requirement in the sense that they are frameworks for quality and long-term communication. To answer Krish’s question, I think that smaller star...

I think everyone made great points regarding documentation, calibration, and clear communication between the Original Equipment Manufacturers and the Contract Manufacturer. Something that hasn’t been ...