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smk45 replied to the topic Sample Size Based on Risk Analysis in the forum Risk Analysis for Medical Devices 8 years, 8 months ago
Hi Abhishek,
After doing some research, I found that conducting a hypothesis test of effects/relationships (power analysis) would be ideal in determining sample size. Studies that attempt to determine an effect such as differences between two treatments or the presence/absence of a certain risk factor need accurate sample size calculations to…[Read more]
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smk45 replied to the topic Factors to Consider While making Gantt Chart in the forum Introduction to Design Controls 8 years, 9 months ago
Hello,
I have yet to gain industry experience, but I do have experience in creating Gantt charts for my Capstone class. A good practice is to start off by documenting what the purpose of the Gantt chart is and then going from there. Your bullet points basically hit the nail on the head on what constitutes a proper Gantt chart. It’s nice to add…[Read more]
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smk45 replied to the topic Minutes for meetings in the forum Introduction to Design Controls 8 years, 9 months ago
The responses on this post do a great job at illustrating why meeting minutes are important. Meeting minutes are there to represent what initiatives a company takes and serves as legal protection. The IRS, courts, and auditors will only look over actions completed by the company if they are documented as minutes, otherwise it does not exist in…[Read more]
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smk45 replied to the topic When is validation is not required? in the forum Introduction to Design Controls 8 years, 9 months ago
Like Hetal mentioned above, it is a good idea to conduct a human factor study even if no changes were required after verification. For medical devices, it is crucial to run the human factors/usability engineering process in order to reduce risks and further ensure that a device can be used safely by patients. By performing human factor studies,…[Read more]
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smk45 started the topic Design Verification & Validation in the forum Introduction to Design Controls 8 years, 9 months ago
While watching this week’s lecture on design control, I tried to figure out the main difference between Design Verification and Design Validation. Both are used to make sure that the design outputs align with the design inputs. They both must also be documented in the Design History File (DHF). Why are these two sections separate though because…[Read more]
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smk45 replied to the topic Consequences Of Insufficient Design Controls in the forum Introduction to Design Controls 8 years, 9 months ago
Hi Lamiaa, thanks for bringing this topic up. From what others have mentioned, it can be seen that the problems that arise from insufficient design control are significant. I wanted to give a couple of examples of medical device failures that have occurred in this year and led to recalls:
1. The company HeartWare recalled their Ventricular Assist…[Read more]
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smk45 replied to the topic What are Design Controls? in the forum Introduction to Design Controls 8 years, 9 months ago
You make an interesting point Lamiaa. It definitely becomes a problem when a company strays away from adhering to their design controls. I am not quite sure what you mean when you say that “when the process becomes heavy, they start following the regulation instead of understanding its intent and main purpose”. I hope you can clarify what…[Read more]
