All three documents are important in their own way in ensuring the safety of medical devices. As a result of the MEDDEV Guidance Documents and Competent Authority Guidance Documents being written by the Competent Authorities, they do not have the authority to approve medical devices. They also cannot audit or inspect, but are able to take a…[Read more]

I have not had any experience in defining the Primary Mode of Action (PMOA) for a combination device. The best way to define the device is by analyzing the two components involved in the product. Based on this, it will narrow down the type of designation the device will be given. In addition, the FDA has Request for Designation that can be…[Read more]

There are many factors to consider when using the multi-center form of clinical study. With this type of study, there could be variations between populations in their genetic makeup, cultural backgrounds, and environmental settings. This could affect comparison of results received from different locations. When doing multi-center trials, it is…[Read more]

The fifth P of marketing, participation plays a very important role in making an effective marketing strategy. With participation, the company promotes a stronger interaction between the employees and customers. As mentioned in the lecture, participation gives the customer control. With the idea of participation, the feedback received by the…[Read more]

It is important that there is a restriction placed on the amount a company put into giving a gift to a physician. If there is no limit set on the amount of money a gift can be then it is likely that the physician will take advantage of the company. In addition, the company should not feel liable for paying for the spouse’s meal. The company i…[Read more]

The consultant does violate the NDA or CDA by copying the template from the previous company. Each company should follow their own template when completing contracts. Although companies are similar in their products and goals, that still doesn’t mean that they are allowed to use the same template. Unless the company whose template is being u…[Read more]

When signing an NDA there are many factors to consider before accepting the contract. As mentioned above, it is very important to pay attention to what is written in the agreement and the time period for which it stands. Another element to keep in mind is to have an understanding of what is considered confidential and the level of…[Read more]

When determining which organizational structure is best for a company, it is important to take the company’s size into consideration. The organizational structure essentially determines the communication between the departments, which will determine the success of a project. Of the discussed organizational structures, the most effective seems t…[Read more]

It is healthy to have a little competition within a company, especially when it is friendly competition. However, if it becomes more than that, it can result in hurting the company’s work and its success. When there is negative competition within a company, it slows down production within the company and end up in failure of the company. It i…[Read more]

When two or more companies come together and decide on collaborating on a project, it is very important that the project is ran smoothly. There are issues that arise within a company when working on a project let alone collaborating with another company. That is why it is vital that there is an organizational structure set in place to keep the…[Read more]

The regulations are highly important in ensuring that the product follows the correct standards and is safe to use in the medical device market. It does seem a little unfair that the company has to pay for the regulations, but don’t even get the full document, only a viewing. Sometimes they do not need document but they already paid for it and i…[Read more]

Project Risk Management works to manage the possible risks a project may have and how to fix it. With Project Risk Management, projects are planned to have fewer risks. With Risk Identification, the risks that could affect the project are identified and listed. As many have already stated, a major factor to consider when doing risk…[Read more]

As stated previously, the risk-benefit analysis is an important, when determining the benefits and risks that need to be considered for a product. One of the factors that is considered in the analysis is postmarket data. When the product is used in reality, a better assessment can be made of the risks and benefits it poses. With the collection…[Read more]

Validation is always an important step in the Design Controls. However, it is not necessarily always needed if there are no changes like you mentioned. Although that might be the case, I feel that a human factors evaluation should still be done. The evaluations are necessary to understand the interaction between the person and the medical…[Read more]

Syringes are commonly used in medical care, such as for intravenous injection in hospitals. Syringes need to be tested and verified before even being used. Some of the tests used to determine the performance of the injector include ANSI, AAMI, ASTM, and ISO. One of the ISO tests includes ISO 11608 which looks at Break Loose, Glide Force, Luer…[Read more]

The Verification step is a very important factor when understanding Design Controls. If the design does not pass the Verification Test, there could be a high risk factor. Although I have not personally encountered an incident when the design does not pass the Verification Test, a major issue that occurs within medical devices is failure of…[Read more]

When determining design inputs it is very important to consider physical and performance traits. These two aspects will determine the used when designing the device. For instance, when considering the customer needs and having portable as one, that means the device should be light weight and not too large. Some other factors that are considered…[Read more]

A Gantt chart gives a detailed schedule in order to complete a project successfully. A major factor in the Gantt chart is the critical path. The critical path ensures that specific steps of the project were completed on time in order the next task to be done. If one task was missed, then the project would fall behind and not go as planned.…[Read more]

Taking minutes in meetings and reviewing them after are very important. They often provide when certain projects are due and what is needed to be completed. If you miss something in a meeting or forget what might have been said, the minutes will give you an overview of everything that was stated in the meeting. This will allow you to stay on…[Read more]

Clinical research allows for the growth of the research being done. Essentially, it includes humans as subjects to determine the effectiveness of the product. One major aspect that needs to be considered is the risk factor. If something goes on with the research, someone’s, or multiple people’s, life is on the line. It could result in fur…[Read more]