Design Validation is a pivotal stage in the product development cycle. I have experience regarding process validation but not design validation. However, user needs need to be met because that is dire...

Communication is key to any project team. Therefore, it is part of the project manager to facilitate an open environment for expressions of any concerns. One should first schedule a meeting with the P...

Typically the Project Manager would be notified ahead of time if it's for a personal leave. If its an unexpected leave, then the PM would need to accommodate and move dates and action items around to ...

The planning phase is very crucial and dictates the direction into which the team will take to accomplish the project goals. Overlapping tasks and projects is a common thing that sometimes inescapable...

In my company, one of the projects I am on closely resembles the second option. The second option is more relatable to a typical medical device product development cycle. One of the main problems is t...

Currently, I work with the Process Validation aspect of our Cardio Surgery devices where I validate test methods. Deviations from protocol do occur every now and then but it is best to avoid them at a...

Scheduling time for each person to complete assignments is definitely a bottleneck or can become one. One way to get around this is to schedule around the persons personal time off and have them appro...

When I attended my first design review meeting, I did not participate much because my project lead and supervisor led most of the discussion. However, I had my validations and other documents prepared...

On a daily basis, I almost always refer to the project plan (gaant chart) to give me guidance regarding the project deadlines and other assignments. This is particularly useful because I see what my a...

Design review meetings at our company are very big in the sense that various members of several departments are invited. There, the project lead discusses the progress and changes in the device and as...

At Getinge, the engineers redline the latest version of the document depending on what changes need to be incorporated which can be given by various inputs of managers, personnel etc. From there, the ...

Engineering change orders allow engineers and others to make changes to documents, parts, etc. Typically one or more potential changes are discussed in a meeting or in a brief conversation. Then the p...

One of the tests I have seen done to check the integrity of the package is known as the burst test. Basically, it works just like it sounds. The package is connected to a machine that increases the in...

I believe that the company needs to decide using a risk-based approach. The medical device industry is governed by risk and because of that each decision made should account for potential setbacks tha...

I agree with puneet as that there aren't many risks involved in performing v&v testing. The risks come into play if the requirements/specifications cannot be verified or need to be changed. If so,...