One of the tests I have seen done to check the integrity of the package is known as the burst test. Basically, it works just like it sounds. The package is connected to a machine that increases the internal pressure until the package seal is broken. This allows packaging and engineering to figure out where the weaker points of the package are and…[Read more]

I believe that the company needs to decide using a risk-based approach. The medical device industry is governed by risk and because of that each decision made should account for potential setbacks that may arise. If the project is a definite source of revenue then it should be pursued. However, if the company has priorities (defined by upper…[Read more]

I agree with puneet as that there aren’t many risks involved in performing v&v testing. The risks come into play if the requirements/specifications cannot be verified or need to be changed. If so, a design change review meeting may need to be held to assess the risk. I currently conduct validation work for a few of our products and I do not run…[Read more]

Requirements for a project proposal are as follows: A description of the product along with its intended use and targeted customers. The market size and selling price should be included. There should be a section that discusses the products specifications based on its user needs. Finally, the addition of estimates to the cost of production and…[Read more]

The quality plan or quality manual of a company shows the commitments of the company to quality and compliance. Upper management has executive responsibility. Some companies adopt clauses written within ISO13485:2016 to show compliance. The Quality Plan is designed to monitor, maintain and control the processes and to drive and sustain the…[Read more]

In my current position, my team and I focus on Design Verification that is within Design Controls. Design Controls is an extremely important guide to engineers within the Medical Device industry. I believe that all of the steps of the Design Control process are relevant to any and all experience because it defines the product development process…[Read more]

Since the FDA sees the Fitbit as a nonregulated device then it will stay as such. If the FDA considered the Fitbit as a medical device then regulations would need to be in place. Given that the device is a consumer health device, the FDA does not want to impose regulations. I personally believe that the FDA should step in to regulate this and…[Read more]

Regulated industries are regulated with reason. Yes, it may hinder innovation however it is to ensure that the devices created are safe and effective for the general public. The regulations placed in the medical device industry are essential and necessary since anyone could potentially create a harmful device. Without these stringent rules, it…[Read more]

Verification and Validation should be done in accordance with Design Controls to ensure proper alignment with correct processes. Verification should be completed after outputs of a design have been established. Then as the device is being reviewed, validation should be conducted as well. I currently am part of the remediation team so I run…[Read more]

As as934 stated, it depends on the business. Upper management decides what the company should focus on given prior experience, etc. Low-priority projects are often put on the back burner because of that main reason – they are not important at that point in time. I do believe that this is correct thinking because, from a business standpoint,…[Read more]

There are other engineering programs that better prepare the student for the given coursework, however, students should also take the initiative to work on their interpersonal skills. Given the nature of the business, students should still invest in school mainly because it is an essential requirement when applying for a job. The system…[Read more]

I believe that this isn’t restricted since bribery isn’t and shouldn’t be taken lightly. As stated in lecture, doctors would receive expensive packages and deals from company employees just so that their products can be favored over others regardless of actual effectiveness. Given that and the amount of abuse these companies and doctors have…[Read more]

Before discussing whether if an NDA acts as a substitute for a patent, it is worth mentioning the differences between the two. A patent is essentially a given right to the inventor saying that he/she or a group of people have the right to the invention from being taken or replicated. This as we know, has a timeline. NDAs however, is an agreement…[Read more]

For one of the company’s projects, myself and other colleagues had to sign an NDA regarding the project circumstances and to not disclose information or penalties will be enacted. Before signing, we had a small forum to discuss and deem what was allowed and not allowed which I would greatly advise ensuring compliance. Now, whether it is obvious to…[Read more]

I would form a project team based on the recommendations from my manager. I would utilize my manager’s experience within the company to create a team that in theory can best perform to execute actions. As the project manager, I would try to avoid problems such as scheduling priority conflicts. I would tackle this issue by communicating with the…[Read more]

The organizational type that is most effective (best) depends on the team members associated with the project. Coming from a matrix organization, I believe that having a strong foundation from management will allow for flexibility of scheduling, however, this is not the case when priority deadlines are due. The most effective organizational…[Read more]

I work as a Quality Engineer in a company that runs as a matrix organization. The management provides excellent guidance to their team on various aspects. Also, the directors amongst the different departments are always willing to collaborate with each other. The issue becomes when deadlines are due for each department and or personnel. With the…[Read more]

As a Quality Engineer, we have AQL levels in place in our drawings for the Quality Inspectors to use when inspecting incoming product that is to be used on the manufacturing floor. As neb2 stated, AQLs are Acceptance Quality Limits which indicate what sample size can be used depending on the requirement being tested on the drawing specification.…[Read more]

My company utilizes FMEA while the planning phase to assess risk. As mentioned in the lecture, FMEA is Failure Mode Effects Analysis. This systematic approach allows primarily those within the healthcare industry to evaluate a process to identify how failure may occur and how can this be handled so the company, hospital, the patient is not…[Read more]

To deal with the high severity of risk would be to assess the potential outcomes that could arise. If at all possible, I would prefer to avoid the risk. This can be established through protocols that aim to move around the risk completely. It is also worth mentioning that the severity may be high however if the occurrence is low then there is no…[Read more]