Design Validation is a pivotal stage in the product development cycle. I have experience regarding process validation but not design validation. Howev...

Communication is key to any project team. Therefore, it is part of the project manager to facilitate an open environment for expressions of any concer...

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 acco...

The planning phase is very crucial and dictates the direction into which the team will take to accomplish the project goals. Overlapping tasks and pro...

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 produc...

Currently, I work with the Process Validation aspect of our Cardio Surgery devices where I validate test methods. Deviations from protocol do occur ev...

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...

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,...

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. T...

Design review meetings at our company are very big in the sense that various members of several departments are invited. There, the project lead discu...

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 i...

Engineering change orders allow engineers and others to make changes to documents, parts, etc. Typically one or more potential changes are discussed i...

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 packa...

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 decis...

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/specification...