Hi all Nice discussion so far.Written agreements are important to avoid risk of genuine mistakes.It is legal way of doing things. Written agreement f...

I would like to share my personal experience.Last semester,I took System Management for Medical Device-online course from Dr.Simon.While as a graduate...

Good discussion so far.I would like to shift a focus little bit.What if you do not have option to pick? Which is the situation in most of the time.In ...

Very interesting topic Lamiaa. I believe it would be more challenging to work in matrix organization for a project manager.In matrix organization,the ...

Good discussion so far! I would like to add more to HACCP-Hazard Analysis Critical Control Point. HACCP process could be divided as following. • Cond...

Agree with all of you! As I was also going through Harvard Business review, they have listed top 6 mistakes made by executives for risk management. Th...

Selection of sample size for clinical study is always critical choice. Few samples do not represent size of target population. On the other hand, more...

Fady Validation is powerful tool to achieve highly effective product. As we all have learned, Verification is to look any flaws in the products, wher...

Hi Roberto You brought interesting topic and good discussion so far. As we are going to work towards our final project I would like to point out what ...

Good Discussion so far. A legacy device is one that incorporated a drug before combination product regulations arrived. Many medical device manufactur...

As per my understanding, Validation is concerned with making sure that the system meets the customer’s actual needs, while verification is concerned w...

I agree with most of you here. The company needs to manage different groups involved in design development, so for such part indeed communication mana...