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 free of the act committed and/or partially makes…   Read more»

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 during the critical phase? This…   Read more»

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: – Medical device development has a…   Read more»

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 Matrix…   Read more»

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 everyone for an answer when an…   Read more»

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 require ISO,…   Read more»

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 regulations show the quality of product…   Read more»

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 identify the hazards associated with medical devices, including…   Read more»

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 will have…   Read more»

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 weigh them and then…   Read more»

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 boring. People from internship…   Read more»

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, in terms of actual processes I…   Read more»

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 regulations and scientific…   Read more»

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 experiment and/or discovery that…   Read more»

The paradox seen here is people want a cure but they do not want to risk their lives for it. You ask the person given the clinical trials If they would risk their own life to save those for the…   Read more»

I notice that one critical step was missed this discussion was taking place. FDA demands animal testing prior to even having clinical trials being a thought. Data collection of the drugs on animals has to be analyzed for efficacy, toxicity,…   Read more»

Going to give a brief summary of the general job responsibilities of a CRA. CRAs is health-care professional who performs many activities related to medical research. Some of those activities can be keeping the GCP’s for monitoring the clinical trials…   Read more»

Marketing to me was and still those tel-marketers calling me at 5:00 pm at night before eating dinner. They tend to be expatriating and annoying. However, It seems when it comes to medical devices the role of marketing is more…   Read more»

This is a fascinating factor to point out in branding. Sometimes people buy products just because of the color, which may sound absurd but it happens. From a website called HelpScout dot com, they go over the “ Psychology of…   Read more»

As Dr. Simon has mentioned in his lecture this week there is 15 grand strategies for marketing. The grand strategy which I will briefly talk on is the Turnaround strategy. From various resources the turnaround strategy is used when a…   Read more»