CMPL stands for Civil Monetary Penalties Law. In general CMPL are as result of mistakes made wither directly or indirectly against the law. As a consequence monetary compensation is required to be fre...

In the paper we were given by Dr. Simon it stated that Patents help to protect your innovation when you are harvesting the fruits of your invention. However, how do you help protect your invention dur...

This is my second online class with Dr.Simon and I knew I would not be disappointed with the amount of information obtained form Dr. Simon. In particular to this course I learned the following: - Medi...

To be a PM for an matrix Organization, as stated by @rv347 is difficult due to more responsibility given to you, more time needed to complete tasks and overall need to love working. So to be a PM of M...

As an intern I noticed that the organization structure was Matrix. However, I noticed a pro and con about the structure. The consequence of having an Matrix organization is that people tend to ask ev...

If you haven’t noticed already the way Dr. Simon set-up the Final Project for the class was a Matrix Organizational Structure. Dr. Simon plays the role as Chief Executive Officer and over sees all tha...

My interpretation of AFAP is twofold: Businesses are doing just enough to be competitive or Businesses are going above and beyond to be the best. In the medical device realm to be the best is to have ...

The regulations are written by people who do this for their career. That means they need a form of compensation. The fee(s) are used to compensate the employees who help write these regulations. These...

For medical devices there is an ISO standard which is ISO 14971. ISO 14971 is the Application of Risk Management to medical devices. In general, it states the specification for manufacturers to iden...

Being part of capstone instilled in me the practical and technical skills of writing a DDP and how you must use “shall” in the document. Also, if you make changes in one document say the DDP then you...

At my internship theirs many design controls set in place to ensure we get good coatings on the ammunition we coat. For example after the bullets have been coated from a basket, I take three parts wei...

From working at my internship I have had meetings in general and not at all related in terms of medical devices however, I notice that when meetings do take place they can be either exciting or borin...

The regulations in the USA vs EU are stricter in terms of documentation. With that being said it seems that the FDA tends to expatriate the companies with documentation where EU is lenient. However, ...

I agree with the DID as being a rough blueprint to the customers input as @amd29 had stated. The example I disagree with because it does not compare to medical devices since their tends to be more reg...

When working in research one must have a lab notebook to document ones findings. There is not many rules to this living document however it should be clear and concise what you are doing for each expe...