I personally felt that this course was very helpful to me, since it provided me with more insight into all the steps required to develop, manufacture, and release a medical device. It was interesting learning about the different departments and…   Read more»

Written agreements are preferable since parties can keep a record of them, they can be submitted as physical evidence in court during disputes, and create a situation where it will be more difficult for one party to unjustly break the…   Read more»

There are several factors that need to taken into account when forming a Non-Disclosure Agreement. This agreement is meant to protect company information such as, trade secrets, client information, the manufacturing process, and sales and marketing plans. In general, NDA…   Read more»

If given the opportunity to choose my team members, I would go for members who are knowledgeable and experts in certain departmental roles. It is important that each departmental role is appropriately fulfilled by a capable team member, since it…   Read more»

I would prefer to work in a strong matrix organization, where balance of power between the project managers and functional heads are less skewed. I believe this type of organization is best, since it forms a collaborative environment that discourages…   Read more»

I agree with some of these posts in that I would like to start with middle management and possibly transition into upper management later on. Upper management is strategic in looking at the big picture and future of the company,…   Read more»

When selecting the method of risk management, I would take into account both the level of severity and occurrence. For high severity and high occurrence risks, I would definitely choose avoidance since that kind of risk is impossible to justify….   Read more»

Since it is impossible for the company to predict what every person using their product will do, the team should always reduce or completely eliminate the possibility and level of harm before they place their product on the market. The…   Read more»

During risk management meetings, the project manager is in charge of facilitating the meeting and making sure that everyone’s inputs are considered. The team will identify the risk, calculate the probability of a hazardous situation turning into harm, and assess…   Read more»

While including all of these parts of the DDP is best practice, I would choose scope management plan and communications management plans as the most crucial. A well designed scope management plan will contain the stakeholders, scope statement, requirements, WBS,…   Read more»

The DID contains the desired inputs of the product. These inputs are more general, but provides all departments a rough idea of what needs to be achieved. The marketing department plays a major role in the DID since it researches…   Read more»

Design verification is a required part of design controls regardless of the type of medical device, but the necessity for validation varies. Verification and validation both take outputs into account, but verification compares it with the inputs and validation compares…   Read more»

If used appropriately, design controls can lead a company to design and produce a product that is a success in terms of effectiveness, marketability, safety, and revenue generation. However, misuse or lack of certain design controls steps can prevent a…   Read more»

Verification is an important part of design controls since it ensures that the inputs match the outputs. It is a way to test the quality and consistency the products, making sure that all the design features of each tested sample…   Read more»

Design controls consist of nine parts, all of which contribute to developing a final product that is innovative, effective, and safe to use. During the planning phase, the project proposal gives management a broad idea of the project scope, demand…   Read more»

I agree with most of these posts in that placebos are both ethical and necessary in testing certain treatments. As long as the patient’s safety is not jeopardized, and the signed informed consent form properly details any risks(which must be…   Read more»

A double blind study provides more assurance that the results of the study are as accurate and unbias as possible. For example, this type of study can be conducted by randomly assigning treatment of oral placebo sugar pills and pills…   Read more»

A clinical background is definitely desired for anyone involved with clinical trials, especially for roles with direct patient interaction. For example, an investigator would really benefit from a clinical background since they will be responsible for ensuring the subject’s/patient’s safety…   Read more»

In my opinion, marketing is resonating with and capturing the attention of the audience by understanding their desires and showcasing why the proposed product will provide fulfillment. The marketing dept. must be experts on the concept of supply and demand,…   Read more»

Emotion intelligence is the ability to acquire and comprehend the emotions of one’s self and others. This skill is required for forging and handling all kinds of interpersonal relationships. In terms of selling, the sales representative will be able to…   Read more»