BenjaminRofail

Forum Replies Created

RE: Time vs. Money

I am slightly perplexed as to why the original post in this thread proposed that the less time a project takes, the less beneficial the project will be. How beneficial a product is to the customer is ...

In forum Project Management Process and Medical Device Development

2 months ago
RE: Are Missed Milestones really Bad?

It does seem that missing milestones is an unfortunate part of the project process. Sure, as aforementioned, missing milestones can lead to overall improvement of the product. That is, if the missed m...

In forum Project Management Process and Medical Device Development

2 months ago
RE: How people try to follow the changing trend.

It is clear that it is the responsibility of the regulatory departments, as well as other members of upper management, to monitor the trends that the FDA is following. Reviewing health and hazard eval...

In forum Project Management Process and Medical Device Development

2 months ago
RE: Project manager flexibility

It is important for any team member, especially the project manager, to be flexible. This means to consider other people's opinions as important, and not to be harsh when things do not go their way. H...

In forum Project Management Process and Medical Device Development

2 months ago
RE: Project Slack Time

I do not think that a project should have a separate portion called "slack time". However, extra time should be added to various steps of the project that are expected to have delay. For example, why ...

In forum Project Management Process and Medical Device Development

2 months ago
RE: Key Questions in Root Cause Analysis

There are various factors that are asked when the task is to find the root cause. Root cause analysis can be likened to a never ending nested doll stack, where one doll is opened to find another. When...

In forum Project Management Process and Medical Device Development

2 months ago
RE: Understanding your role...

I don't believe it is wrong to state that there should always be a leader in the group. As life, and many novels and stories will tell us, groups tend to fall apart if there is no leader. Having a lea...

In forum Introduction to Project Management

2 months ago
RE: The Importance of the Design History File (DHF) in Regulatory Compliance

Based on my experience in the biomedical industry so far, every change in the product should be traceable. Even in basic or routine analysis or documentation, traceability and having a path to demonst...

In forum Introduction to Project Management

2 months ago
RE: Examples of budget changes due to DSD testing

While I understand the viewpoint that budget changes should be expected in a project plan, if the DSD is well specified, large shifts should not be highly expected. Shifts in budget usually occur for ...

In forum Introduction to Project Management

2 months ago
RE: Remote or In-Person PM

Flexibility and balance are needed in every aspect of life, and the same goes for companies and managers allowing both in person and remote work. Both methods of working have benefits, and too much of...

In forum Introduction to Project Management

3 months ago
RE: How to communicate effectively between team mates in project team ?

There are many things to do in order to ensure that proper communication takes place in the workplace. Although the following step may seem to be counterintuitive, it is extremely important and effect...

In forum Introduction to Project Management

3 months ago
RE: Seeking Insights on working as a Project Manager in the Medical Device Field

Although I myself have not worked as a project manager, my work experience has allowed me to be extremely familiar with the work of a project manager. I worked with some project managers over the cour...

In forum Introduction to Project Management

3 months ago
RE: Project Management for Non-PM Positions

From my work experience, project management is an essential part of any successful working experience. Project management skills of cooperation, team work, conflict resolution, and being approachable ...

In forum Introduction to Project Management

3 months ago
RE: Leaders: Nature or Nurture?

I believe leadership qualities are a combination of innate characteristics and learned characteristics. However, the greater portion belongs to learned behavior. If we are speaking with regards to chi...

In forum Introduction to Project Management

3 months ago
RE: Difference between drug and medical device?

There are several differences and similarities between medical devices and pharmaceutical drugs. Now, whether a pharmaceutical product is a medical device (drug delivery systems) is a separate convers...

In forum Introduction to Project Management

3 months ago
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