I believe in order to use an unapproved device, Physician’s must understand their role and responsibilities. And also understand when an emergency is to use an unapproved device. For a situation to be an emergency, there must be a life-threatening disease or serious condition which is requiring immediate use. There is no generally accepted…[Read more]

Once a product is in the market for the public to use, any unpredictable problems can lead to a recall. However, recalls are always voluntary. Sometimes a company discovers a problem and recalls a product on its own without consulting FDA. Other times the company recalls a product after the FDA raises concerns regarding their product. For any…[Read more]

For every medical device, whether it involves risk or not, it needs to be regulated by FDA. And the center that regulates the medical devices is CDRH which is the Center for Devices and Radiological Health. They review and approves medical devices. Each device is classified into class I, class II, and class III. Class I are the most general…[Read more]

A risk management plan is a crucial step in a project. It helps to identify risks and implement a plan to reduce them. It helps the members to foresee risks, identify actions to prevent them from occurring and reducing their impact. It also mentions the risk based on ranking and priority, and the process of tracking the risks. Throughout the…[Read more]

I think quality planning is a critical part of any project in the medical field. It allows an individual to agree on a set of quality targets with your customer. A quality plan helps you to schedule all of the tasks needed to make sure that the project meets the needs of the customer. It comprises two parts which are the quality assurance plan and…[Read more]

Certain companies ask an employee to sign an NDA (non-disclosure agreement) in order to protect their trade secrets. The reason being it allows their company to operate at a higher level and less risk. Things you should consider before signing an NDA is to make sure the definitions of proprietary and confidential information are thoroughly defined…[Read more]

The difference between the verbal agreements and written agreements is that the written agreement is definitely easier to create, understand, and can be used as a proof to prove to someone or in court when there is a disagreement. While with the verbal agreement, both parties are depended on the words being said to each other and third party can…[Read more]

certainly, I agree with most of the participants in this post regarding Dr. Simon’s class. This is my first time taking the class with Dr. Simon. I am glad I took this course. I found this course helpful, therefore I took Dr. Simon second course as well for next semester. During this course, I learned more about all the inside position and the d…[Read more]

We had our first meeting on Friday after the initial meeting where we formed a team. We meet every Friday at 7 pm on Google Hangouts through a conference call to share our perspective status of the project with every member of the team. The reason being, all of us are able to share our responsibilities, its timeline, and raise any questions if…[Read more]

I believe in my opinion, the best way to form a project team would be with people who are more knowledgeable in their department role rather than working with people who you have a better relationship with. The reason being, with people being expertise in a certain field will help you perform a specific task from your group member. This will help…[Read more]

I agree with many of the participants in here, matrix organization would be the best option to start my medical device company. There are many reasons, but one of the particular is that matrix organization is a combination of Project manager, Functional heads and Project teams. Certainly, that project managers make the project team but project…[Read more]

There are several approaches used to manage risk in a project as mentioned by many in here. The fundamental steps for risk management are to establish the goals and context, identify risks, analyzing the identified risks, asses or evaluate the risks, manage the risks, monitor and review the risks, and continuously communicate. Communication is…[Read more]

All risk is valued by Failure Mode Effects and Criticality Analysis (FMECA). It is an approach to analyze risk. Certain factors that contribute to determining the risk values are how something can fail, the severity of the consequences, and the probability that it will fail. The severity, significant and minor is evaluated with high, intermediate,…[Read more]

As it was discussed in the slides by dr.simon, Risk management plan identifies and evaluates all the risk. One method that analyzes risk is by FMECA which stands for Failure Mode Effects and Criticality Analysis. Then documentation reviews take place where the list of all risks are assessed and evaluated through FMECA. A solution is to the risk is…[Read more]

According to FDA, design control makes us demonstrate compliance with codes and it has nine parts. These nine parts are Planning, Input, Output, Review, Verification, Validation, Transfer, Design Changes, and Design History File. Each of these nine parts has their own documentation to go along with it. Each document includes the importance of the…[Read more]

Regarding the Gantt chart, I have yet to gain experience in the industry, but from my senior year capstone course, I do have experience in creating Gantt charts. A simple and basic essential you need to start the chart is by documenting the purpose of the project and steps in order to accomplish that project. After that start adding milestone that…[Read more]

The purpose of doing meeting minutes is to have everyone on the team and everything related to the project straighten out in order. It helps you to remember what was discussed in the meeting, where did it happen, who attend it, who made the decisions and what decisions were made. After each meeting whoever was writing/typing the minutes of the…[Read more]

Similar to mentioned already, validation is the process of making sure that the objectives meet the user needs and intended uses have met. certain methods that verify these details are through inspections, clinical trials, and design analysis. After the design verification has completed, the design validation is still must to assure all objective…[Read more]

Design Development Plan is certainly the crucial component in a project. DDP ensure traceability of design and development outputs and inputs to design. I think the quality management plan is more important than communication plan. The quality unit has the responsibility and the authority to approve or reject all components, product elements,…[Read more]

Indeed, it is important that medical system companies design and develop a medical device that is safe and efficacy for the consumers to use. FDA, IND and other regulatory organizations want to regulate the product and assure that the medical device is safe and efficacy before it is sent into the market. The significance of Design control is that…[Read more]