Medical Device Courses | carrissap10 | Activity

carrissap10 replied to the topic "Written Agreement v/s Verbal Agreement" -

Sun, 27 Jun 2021 19:44:09 -0400

I believe there is a huge different in a written agreement and verbal agreement. In a verbal agreement anything could be said and there is really no true follow-up or verification for the agreement that occurred. In a written agreement… Read more»

carrissap10 replied to the topic "Your Organizational prference; but why?" -

Sun, 27 Jun 2021 19:40:45 -0400

The matrix organization is my preferred method to work in. This allows everyone to work freely and information is easily shared between project teams and members. I believe the power is not focused solely on a manager and the team… Read more»

carrissap10 replied to the topic "Forming a Project Team" -

Sun, 27 Jun 2021 19:36:12 -0400

I think it would be best to work with people that have knowledge and specialize in specific areas. They can bring there knowledge and work together on project. The different aspects will help prepare the team. Of course key tools… Read more»

carrissap10 replied to the topic "Risk Management - Identification" -

Mon, 21 Jun 2021 03:14:44 -0400

In order to identify the risk you must brainstorm and predict the risk before they occur. You must evaluate the safety and effectiveness of the device. This will help you or a team identify the risk. You may also compare… Read more»

carrissap10 replied to the topic "Risk Management Tools" -

Mon, 21 Jun 2021 03:11:00 -0400

Each risk management tool is important. In the past I have used the brainstorming tool. When working with others or alone brainstorming was implemented. We came up with ideas that include the limitations of the risk, and also thought of… Read more»

carrissap10 replied to the topic "What is Risk-benefit analysis ?" -

Mon, 21 Jun 2021 03:07:32 -0400

The risk benefit analysis is important for medical devices that are developed. The benefits need to outweigh the risks to have a safe and effective medical device. The risk benefit analysis will determine the availability of a product. If the… Read more»

carrissap10 replied to the topic "a successful validation process" -

Sun, 13 Jun 2021 17:43:25 -0400

To have a successful validation there important aspects to the validation. These key components include making sure that the design control and process is verified. Another aspect is making sure that the customers and the medical device company demands have… Read more»

carrissap10 replied to the topic "Design Controls: What do you deem most important?" -

Sun, 13 Jun 2021 17:38:39 -0400

I believe the customers input is the most important section. I believe there input could validate sells as well as marketing. While designing the device you can know what to target and focus on to accommodate the customers. You also… Read more»

carrissap10 replied to the topic "When is validation is not required?" -

Sun, 13 Jun 2021 17:35:38 -0400

Even if we have passed the verification phase, I believe that if human subjects are involved there needs to be validations. They could change some of these requirements due to humans being involved. If everything is not validated then its… Read more»

carrissap10 replied to the topic "Clinical Studies" -

Sat, 05 Jun 2021 18:50:23 -0400

The advantages of clinical studies include discovery of new medications, devices and treatments. This could include fewer problems or side effects of current treatments. A new medication may also work stronger and faster than a previous medication as well. Finding… Read more»

carrissap10 replied to the topic "Discussion Topic: Having a "clinical background"" -

Sat, 05 Jun 2021 18:44:54 -0400

I believe being a Clinical Research Associate should require a clinical background. I believe that clinical research involves being hands on with lab equipment, or subjects that are involved within the clinical trials. The trials could include animals or humans… Read more»

carrissap10 replied to the topic "Ethical Issues with Clinical Trials" -

Sat, 05 Jun 2021 18:41:43 -0400

I believe that human subjects should be exposed to life threatening clinical trials when there is a life alternating, or dying disease available. I believe that this is a sacrifice of the small for the many. Thousands of people could… Read more»

carrissap10 replied to the topic "Brand Coloring" -

Sun, 30 May 2021 17:02:04 -0400

The color that I notice for most companies or businesses is the color blue. In general blue has a positive impact. Examples include water, or the sky which represents calmness and tranquility. This color positively affects the mind body and… Read more»

carrissap10 replied to the topic "Marketing Clinical trials And Recruitment" -

Sun, 30 May 2021 16:58:53 -0400

In order to recruit I would really dive deep into the community and interact with people within the community. Listen to there issues and try to relate to them. I would inform them about the impact that they would have… Read more»

carrissap10 replied to the topic "Accepting job based on company." -

Sun, 30 May 2021 16:54:21 -0400

This is a great question. Me personally being fresh out of college, after completing my undergrad I would not turn down a job based on label of the company. I believe that at the entry level all jobs should be… Read more»

carrissap10 replied to the topic "RECALLS" -

Sun, 23 May 2021 22:13:56 -0400

On average there are around 50 to more recalls in a year within the medical device industry. I have heard about the Abbott cardiac pacemakers recall. There were over 400,000 devices created and sold. The device had issues with exposed… Read more»

carrissap10 replied to the topic "Drugs banned in US but not in other countries" -

Sun, 23 May 2021 21:53:02 -0400

Other countries including India, have certain drugs that are not banned. There drug laws and policies are different compared to the United States. Within the United States the safety and effectiveness of drugs is taken very seriously. They ensure that… Read more»

carrissap10 replied to the topic "510K is Nonsense" -

Sun, 23 May 2021 20:50:34 -0400

I agree with the initial statement made regarding this topic. I believe that all medical devices should be assessed at there own merit, especially due to advances in technology. However, I do believe when medical devices are being developed, they… Read more»

carrissap10 replied to the topic "Animals Used in Animal Testing" -

Mon, 17 May 2021 02:42:39 -0400

I believe the line should be drawn for certain animals. In this case I believe these animals include pets such as, dogs, birds, and cats. I do believe apes should be experimented on, because they are the animal that closely… Read more»

carrissap10 replied to the topic "This vs That" -

Mon, 17 May 2021 02:39:33 -0400

There are many differences when as it pertains to the Academia and Industry department of medical devices. First the salary is higher for the industry department by a huge margin. The Academia department also has to fight for grants to… Read more»

carrissap10 replied to the topic "Ethics of Animal Testing" -

Mon, 17 May 2021 02:30:51 -0400

Being that I am a dog owner of two amazing Pitbull’s, I believe that there could be another way to experiment with animals. The animal testing should not have to require an animal losing their life. There are plenty of… Read more»

carrissap10 replied to the topic "Ethics of Animal Testing" -

Mon, 17 May 2021 02:30:08 -0400

carrissap10 replied to the topic "Discussion Topic: Covid19 and medical devices" -

Sat, 08 May 2021 00:20:17 -0400

Covid-19 has impacted the healthcare industry in a huge way! Whether its vaccines, medical devices, or drugs this virus has made researchers, nurses, doctors, technicians, and companies develop new resources to help diagnose/treat these disease. The medical equipment being developed… Read more»

carrissap10 replied to the topic "Thoughts on BS, MS, and PhD in BME" -

Sat, 08 May 2021 00:11:50 -0400

I believe that the best education to obtain before entering the industry, is a Masters Degree. I believe that obtaining a Bachelors degree only gets you hired by entry level jobs that do not require experience. In todays generation having… Read more»

carrissap10 replied to the topic "Thoughts on BS, MS, and PhD in BME" -

Sat, 08 May 2021 00:11:28 -0400

carrissap10 replied to the topic "Discussion Topic: Academia vs. Industry" -

Fri, 07 May 2021 15:58:20 -0400

When dealing with academia versus the industry there are many differences. In the Academia area you are dealing more with the education and laboratory setting. Within this setting you tend to work more individually and while working by yourself you… Read more»

carrissap10 replied to the topic "WBS Pitfalls" -

Sat, 24 Apr 2021 20:34:25 -0400

The Work Breakdown Structure is crucial to for a successful team and a successful project. It explains the project scope and breaks down the task needed to be completed for the project. This also allows project managers to identify any… Read more»

carrissap10 replied to the topic "Categorization of Medical Devices" -

Sat, 24 Apr 2021 20:17:56 -0400

Medical devices are categorized in three classifications. The classes range from Class One to Three. These classifications are based off the harm that these medical devices present. The FDA classifies and groups these medical devices based on safeness and effectiveness…. Read more»

carrissap10 replied to the topic "Project Manager Skills" -

Sat, 24 Apr 2021 19:51:00 -0400

I believe that project managers need a lot of skills in order to succeed. These skills can include leadership, cost management, risk management, critical thinking, and team planning. However, the most important skill is communication. As a project manager he/she… Read more»

carrissap10 replied to the topic "Medical Devices" -

Mon, 19 Apr 2021 04:26:42 -0400

Failures can occur within the biomedical field through research, development, selling, distributing, and marketing. However, when executing a project, if a failure occurs during research, the team members and PM should evaluate this problem and plan to execute a new… Read more»

carrissap10 replied to the topic "Preplanning for Risk" -

Mon, 19 Apr 2021 04:16:55 -0400

When planning a project, time management is key for the success of the project. A schedule must be set for each task, to be completed by a certain time frame. In terms of risk management and ES, EF, LS, LF… Read more»

carrissap10 replied to the topic "Things to look for in a contract while selecting a supplier" -

Mon, 19 Apr 2021 04:08:30 -0400

There are many options to consider when selecting a supplier and looking over a contract. First you should make sure that everything you and the supplier discussed verbally is included in the contract. Any new or extra information should be… Read more»

carrissap10 replied to the topic "Risk Management impact" -

Sun, 11 Apr 2021 16:14:43 -0400

Risk strategies are put in place to avoid risk impacting a project. Risk management is a key process that project managers must include when working to complete a project. A risk that I was faced with included working with other… Read more»

carrissap10 replied to the topic "Medical device" -

Sun, 11 Apr 2021 16:06:27 -0400

If the devices is non-invasive it can still be categorized as a class 1 medical device. All medical devices do need a 510k to be classified as a medical device. This is the same for medical devices that do or… Read more»

carrissap10 replied to the topic "Changining staff" -

Sun, 11 Apr 2021 15:58:58 -0400

Changes are made during a project all of the time. People should prepare for changes within the budget, tasks, supplies and team members. When a team member changes positions and are assigned a different task. Some one else must step… Read more»

carrissap10 replied to the topic "Communication is the way" -

Mon, 05 Apr 2021 00:02:25 -0400

Before starting a project there are many skills that are necessary to have as a team member. Being able to collaborate with other team members, the project manager, and stakeholders is crucial for the development of the project. Leadership skills… Read more»

carrissap10 replied to the topic "Class II Medical Devices" -

Sun, 04 Apr 2021 23:49:15 -0400

Medical devices are labeled based on there efficacy and safety of the product being developed. Clinical trails being conducted on medical devices is determined based on the possible threats that these classes could pose on humans, or the subjects. These… Read more»

carrissap10 replied to the topic "Validation and Verification" -

Sun, 04 Apr 2021 23:24:51 -0400

Validation and verification are both lengthy tasks that could possibly take longer than the scheduled outline for the project. When validating a project you are insuring that that the functional requirements of the project are in order to work. If… Read more»

carrissap10 replied to the topic "Your ideal PMO type?" -

Sun, 28 Mar 2021 16:31:01 -0400

I believe that a supportive but yet direct project management style would be best for me. At this stage in my career would be placed at an entry-level job, so being new into this area of work, I would help… Read more»

carrissap10 replied to the topic "Does Organizational Structure change how you prioritize ?" -

Sun, 28 Mar 2021 16:25:20 -0400

My organizational skills keep me on track for day to day, and work related tasks. Having organization for your tasks, causes you not to stress, and allows you to focus harder on the tasks at hand. This helps me maintain… Read more»

carrissap10 replied to the topic "The effect that organizational structures have on project management" -

Sun, 28 Mar 2021 16:18:01 -0400

Organizational structures can have positive and negative outcomes on a project. The functional organization allows for projects to be coordinated easily within the same department due one person being in charge. However, if the project is done with multiple departments… Read more»

carrissap10 replied to the topic "Importance of Human Resource Management" -

Fri, 19 Mar 2021 17:35:31 -0400

Human Resource management impacts the success of a company in a huge way. To reduce turnover and hire for fit will help the medical field, because you are hiring the correct staff that will help the production of your company…. Read more»

carrissap10 replied to the topic "Communication Management" -

Fri, 19 Mar 2021 17:08:31 -0400

Within a project communication is key. Therefore I believe every involved in the project must communicate. However, I believe it is the project managers job communicate and set up the organization of the project. If the members involved in the… Read more»

carrissap10 replied to the topic "Human resource management" -

Fri, 19 Mar 2021 16:48:54 -0400

I agree with kbentleymsm-edu this is very poor planning. I am sure the company was aware that she was pregnant and had more than enough time to prepare for her maternity leave. Therefore this issue is poorly managed. I believe… Read more»

carrissap10 replied to the topic "Overlapping activities" -

Sun, 14 Mar 2021 20:28:01 -0400

Hey everyone, I agree with @ial4 post. Returning to an earlier phase does not mean your moving backwards. Going back to an earlier phase may actually help you reach your goal at a faster rate. There could be additional… Read more»

carrissap10 replied to the topic "Executing Process" -

Sun, 14 Mar 2021 19:25:11 -0400

@djwhitemsm-edu I agree with your response. Planning can not be completed with out execution. These plans have to be put in to effect in order to even make the plans become possible. However, I believe between distribution, solicitation, source selection,… Read more»

carrissap10 replied to the topic "Project Execution" -

Sun, 14 Mar 2021 19:03:55 -0400

During a project there are different process phases that must take place. The planning and execution phases are very vital to the production of a successful project. Planning takes time and deduction to creating the correct timeline needed to produce… Read more»

carrissap10 replied to the topic "Team member skills" -

Sat, 06 Mar 2021 23:14:45 -0500

As a project manager there are multiple skills that they should look for when selecting future team members for a successful project. As @ssbufford stated hard skills and soft skills are important skills that should be evaluated very carefully. I… Read more»

carrissap10 replied to the topic "Emotional Intelligence" -

Sat, 06 Mar 2021 23:08:49 -0500

I truly believe that emotional intelligence does have a huge impact on the success of a team. While working with a group I had to evaluate my own emotional intelligence, in order to have a successful outcome when working on… Read more»

carrissap10 replied to the topic "Project manager's personality: Project success" -

Thu, 04 Mar 2021 20:03:45 -0500

I do believe competency goes hand and hand with personality because the ability to do something successfully is based on an individual’s personality. Based on an individual’s personality they may be an introvert or extrovert. However, their personalities should not… Read more»