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bsk32 replied to the topic "Enhancing Quality Assurance: Lessons from the DePuy ASR Hip Recall" – 2 weeks, 5 days ago
I have experience as a Quality Engineer. One of my tasks was to manage the equipment maintenance schedule and order calibration services. During production of the devices, my team and I would catch equipment or other processes being done out… Read more»
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bsk32 replied to the topic "The Crucial Role of Regulatory Compliance in Medical Device Innovation" – 2 weeks, 5 days ago
I think in order create an innovative design that passes all regulatory compliance, it should have an effective Validation Plan. The validation method is required to test the device’s safety and effectiveness, and the results to prove its safety and… Read more»
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bsk32 replied to the topic "Planning Techniques" – 2 weeks, 5 days ago
Although I worked for a company before with a Team, I don’t have experience Initiating and Managing a Project. I think that as an Engineer becomes more experienced with managing many projects in their career, every process in the project… Read more»
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bsk32 replied to the topic "Time vs. Money" – 1 month ago
In order to reduce the time and money needed for a project while also increasing the chance for a successful product is to gather up all previous meeting minutes, schedules, and procedures for previous successful projects. Those can be used… Read more»
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bsk32 replied to the topic "Making connections between people and schools" – 1 month ago
Hi everyone. My name is Brandon Klavansky, and I’m a BME MS student at NJIT. I’m looking forward to connecting.
http://www.linkedin.com/in/brandon-klavansky-b66479208 -
bsk32 replied to the topic "Email Communication" – 1 month ago
I think that email communication is used for official information that includes meeting invites, task delegations, and announcements from the manager. Most companies will use a VPN with a private email server in order to protect sensitive information. Microsoft Teams… Read more»
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bsk32 replied to the topic "Project Slack Time" – 1 month, 1 week ago
I think it depends on what you mean by Slack Time. Unexpected delays can happen and extra time should be given for cases such as failure in Validation or Verification phases. Although it’s initially costly, the time given is valuable… Read more»
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bsk32 replied to the topic "Value of Design Controls" – 1 month, 1 week ago
I agree that feasibility studies will improve the chances of success in the Design Control process and help a project lifetime. Innovative projects are often higher in risk, an can result in the scenario described above, where they discovered a… Read more»
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bsk32 replied to the topic "Effective Scheduling in Medical Device Development" – 1 month, 1 week ago
Using ES, EF, LS, and LF is very helpful for planning for any contingencies. Many factors can cause delay in a schedule such as not thoroughly examining Project or Design Inputs. A device may have required more feasibility data, and… Read more»
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bsk32 replied to the topic "Should procedures or standards for verification and validation tests be approved by the FDA?" – 1 month, 2 weeks ago
I agree with @gdecarvalho22 above that the FDA indirectly approves the tests as long as the final design and design process shows to comply with FDA standards. If the test parameters are not within what the company claims for either… Read more»
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bsk32 replied to the topic "A Hypothetical Perspective about the First Simulation" – 1 month, 2 weeks ago
Hypothetically, if the bottles are meant to be stored in 37C due to its contents, then we can’t change the testing parameters. The bottles’ labels must be able to stay adhered to the bottle at 37C. In this case, we’d… Read more»
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bsk32 replied to the topic "Verification Failures and Adjusting Test Conditions" – 1 month, 2 weeks ago
When Verification tests fail, I think that the best approach is to first evaluate whether the model still fills the need of the customer. The testing parameters could’ve been set incorrectly because they excluded a large amount of customers. In… Read more»
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bsk32 replied to the topic "Project Management for Non-PM Positions" – 1 month, 3 weeks ago
In my personal experience, I had to jump into a role working with a team in a functional organization, not yet knowing how organizations worked and the meaning of the tasks I was doing. Know that I know how projects… Read more»
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bsk32 replied to the topic "Test Method Validation" – 1 month, 3 weeks ago
The Design verification and Validation test the design of your product. In an experiment, there are always statistical analysis to determine the significance of the results to prove or disprove the hypothesis. The Test Method Validation is to predict the… Read more»
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bsk32 replied to the topic "Determining Spec" – 1 month, 3 weeks ago
Determining the spec with tolerances is the most important part in the effectiveness of the design. It really depends on the application and market in my opinion. If it is an orthopedic implant, there should be a plan included to… Read more»
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bsk32 replied to the topic "Misclassification of a Device?" – 2 months ago
I agree that those devices may need to be regulated by all three sub-agencies. If the design contains any drug or biologic components, the other agencies might come after us if we don’t get those components approved by them. I… Read more»
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bsk32 replied to the topic "Pre-market Approval (PMA) vs. 510(k)" – 2 months ago
A 510(k) is used for class II devices which rely on a predicate device for its design and purpose. If the device is the same category as a long existing device, this form can use the older device as a… Read more»
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bsk32 replied to the topic "Handling Conflicts Among Team Members Effectively" – 2 months ago
In order to handle conflicts effectively, we should have open communication from the beginning of the project. Managers need to share what is expected of their employees before the start of the project. One way to handle conflicts is to… Read more»
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bsk32 replied to the topic "Design Verification Failures" – 2 months, 1 week ago
If the cause of failure was with the device design, then verification will take longer, and the timeline should be anticipated to be pushed back. As a project manager, I would confer with the Engineering team to conduct a root… Read more»
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bsk32 replied to the topic "Balancing Stakeholder and Customer Values" – 2 months, 1 week ago
I think where the value goes depends case-by-case. Those decisions are often made before creating a project, and involves outlining the strategy and analyzing the market and economy. If the market and economy favor the needs of customers that aren’t… Read more»
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