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 formally prevents one party from making the same ver...

There are majorly 5 types of federal fraunds. (1) False Claims Act(FCA) (2) Anti-kickback Status(AKS) (3) Referral/Stark Law (4) The Exclusion Authorities (5) Civil Monetary Penalties Law(CMPL) As i w...

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 student when i went to give my first in person in...

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 such cases one should have to look up for strategi...

As Dr.Simon have stated organizational behavior is very important to improve performance. Recently i came across one interesting paper on organizational behavior management in healthcare. Organization...

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

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

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. They are, • Risk is not only determined by predictin...

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 samples than required put more individuals to the...

Fady Validation is powerful tool to achieve highly effective product. As we all have learned, Verification is to look any flaws in the products, whereas Validation is necessary for judging it through ...

As we all know before setting up Gantt Chart we should have detailed project plan. Some important factors while preparing Gantt Chart are, • Defining clear project settings. • Start date and end date....

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 to include when writing down meeting minutes. • Da...

Good Discussion so far. A legacy device is one that incorporated a drug before combination product regulations arrived. Many medical device manufacturers have mistakenly assumed that since legacy prod...

As per my understanding, Validation is concerned with making sure that the system meets the customer’s actual needs, while verification is concerned with whether the system is well-engineered, error-f...

I agree with most of you here. The company needs to manage different groups involved in design development, so for such part indeed communication management plan is very essential to mention responsib...